Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Each participant of the study will provide exhaled breath condensate sample and blood sample for further laboratory analyses. Each participant will have LDCT (low dose computer tomography) performed. A pulmonologist examines the patient for any concomitant diseases and performs spirometry. Vital signs will be measured.

Patient will breath for approx. 10 minutes to a breath condenser. The exhaled breath sample will be condensed and freezed.

Exhaled breath condensate sampling

A venous blood sample will be taken for further biomarker analysis.

Blood sampling

LDCT

Blood pressure, weight, height, pulse, oxygen saturation will be measured.

Vital signs

Spirometry

Marian Hajduch, MD, PhD.

Michaela Bendova, MSc.

Pavel Turcani, MD, PhD.

Martina Lojova, MSc., PhD.

Petr Jakubec, MD, PhD.

Miroslav Herman, prof.MD PhD.

Jiri Votruba, MD, Ph.D.

Lenka Navratova, MD

The trial will evaluate if the newly identified biomarkers of lung cancer in exhaled breath condensate are as a diagnostic tool comparable to the low-dose computer tomography (LDCT) implemented in lung cancer screening recently. Due to the possibility to collect breath condensate at any medical workplace and due to the relatively low financial cost of examination of the collected breath condensate could improve early diagnosis of lung cancer, differential diagnostics of lung nodules and thereby reduce both the unnecessary interventions and deaths from this type of cancer.

The project aims to validate newly identified biomarkers of lung cancer in breath condensate for the diagnosis and triage of lung nodules (malignant versus benign), further set the mechanisms of the functioning of the lung cancer screening center, validate the quality indicators of LDCT screening for the Czech Republic and stratify the cohort of individuals so that optimized output of screening activities. Patients aged 55-74 years with a heavy smoking load (more than 20, preferably more than 30 pack/years) will be divided into risk groups according to biomarkers in exhaled air, clinical/anamnesis data and the degree of obstructive ventilation disorder according to spirometry and subsequently there will be effective stratification of the risk of lung carcinoma. The group with the highest risk of developing lung cancer will then be diagnosed with early lung cancer using ultra-low-dose computed tomography of the chest. This will lead to early diagnosis and subsequently to a reduction in the mortality rate of the monitored active group compared to the historical cohort. The primary outcome will be the validation of the multiplex protein signature in exhaled air, the effectiveness of the screening procedure to reduce lung cancer mortality and overall mortality in the group with FEV1 (forced expiratory volume at 1 second) pre-bronchodilation 60-75% with the entire group of examinees. The secondary outcome will then be the total time of diagnosis of a solitary pulmonary nodule in positively screened patients for whom only observation is not a sufficient procedure. Another secondary outcome will be the costs of screening procedures for individual groups and the percentage of success of the anti-smoking intervention for the enrolled individuals. The number of newly captured interstitial lung processes will also be evaluated. Patients will be evaluated for 5 years at annual visits or earlier based on their LDCT result.

Study of Early Cancer Biomarkers in Breath Condensate in Population of Individuals With High-Risk of Lung Cancer Undergoing LDCT Screening.

Prospective Validation Study of Early Cancer Biomarkers in Breath Condensate of Individuals With High-Risk of Lung Cancer Undergoing Low-Dose Computer Tomography Based Screening.

The number of newly captured interstitial lung processes will also be evaluated.

Validation of the multiplex protein signature in exhaled breath condensate based on the comparison with the LDCT.

Validation of the multiplex protein signature in exhaled breath for differential diagnostics of lung nodules

Assesment of the effectiveness of the screening procedure to reduce lung cancer mortality and overall mortality in the group with FEV1 (forced expiratory volume at 1 second) pre-bronchodilation 60-75% compared with the entire group of examinees.

The total time of diagnosis of a solitary pulmonary nodule in positively screened patients for whom only observation is not a sufficient procedure.

Comparison of the costs of the screening procedures for exhaled breath condensate sample and LDCT procedure. This will be asssessed based on the individula patient data: total screening costs per patient from Healthcare registry in Czech Republic.

Percentage success of the anti-smoking intervention in the examined probands.

Cancer Research Foundation CR

The Institute of Molecular and Translational Medicine, Czech Republic

Infections

Symptoms and General Pathology

Carcinoma

Carcinoma, Non-Small-Cell Lung

Pneumonia

Communicable Diseases

Respiratory Tract Infections

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Immunomodulating Agents

Dimercaprol

Chelating Agents

Antineoplastic Agents, Immunological

Patients undergo collection of blood, stool and saliva samples at baseline. Patients will also have a 6 minute walk and standard of care pulmonary function test at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 10 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and No BAL sample is collected at week 10. During the course of treatment, patients also complete routine tests and procedures to monitor for side effects per standard of care including CT within 4 weeks, lung function tests including home spirometry TIW from week 10-62, bronchoscopy and/or a nasal wash to check for viral infection. Patients also complete questionnaires about symptoms and quality of life QW for weeks 1-10, BIW during weeks 10-62.

Undergo collection of blood, saliva, stool, and bronchoalveolar lavage samples

Biospecimen Collection

Bronchoscopy with Bronchoalveolar Lavage

Undergo concurrent chemoradiation per standard of care

Chemoradiotherapy

Computed Tomography

Diagnostic Laboratory Biomarker Analysis

Immune Checkpoint Inhibitor

Nasal Wash and Collection

Quality-of-Life Assessment

Questionnaire Administration

Ajay Sheshadri, MD

Ajay Sheshadri

This study looks at the side effects of chemotherapy and radiation (chemoradiation) followed by immunotherapy in patients with non-small cell lung cancer, with a particular focus on lung inflammation (pneumonitis). By collecting blood, stool and saliva samples, and data from lung function tests, researchers may be able to create a database of information about treatment and side effects in patients with non-small cell lung cancer who are receiving chemoradiation followed by immunotherapy. The information gained from this study may also help researchers find signs of problems with lung function earlier rather than later, since lung function is checked more often than routine care. This may improve how quickly these issues can be treated, and future patients may benefit from what is learned.

PRIMARY OBJECTIVE:

I. To assess the association between the incidence of concurrent chemoradiation and subsequent immunotherapy-related adverse events, particularly radiation and immune-related pneumonitis, in patients with non-small cell lung cancer (NSCLC), and various clinicopathologic, radiologic, tumor, and demographic covariates of interest.

SECONDARY OBJECTIVES:

I. To correlate clinicopathologic, radiologic data and tumor characteristics with systemic longitudinal assessments of blood biomarkers for toxicity and response to therapy.

II. To monitor home spirometry and symptoms to identify early pneumonitis. III. To collect blood and microbiome samples from patients on immunotherapy and biopsy samples from toxicity sites at the time of toxicity to evaluate predictive markers for therapy related adverse events.

IV. To determine the effect of concurrent chemotherapy followed by immunotherapy on sleep quality.

V. To determine the impact of sleep disturbance on gut and oral dysbiosis. VI. To characterize longitudinal changes in fatigue and financial toxicity with concurrent chemotherapy followed by immunotherapy.

OUTLINE:

Patients undergo collection of blood, stool and saliva samples at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 62 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and samples at week 10. During the course of treatment, patients also complete routine tests and procedures to monitor for side effects per standard of care including computed tomography (CT) within 4 weeks, lung function tests including home spirometry three times a week (TIW) from week 10-62, bronchoscopy and/or a nasal wash to check for viral infection. Patients also complete questionnaires about symptoms and quality of life once a week (QW) for weeks 1-9, twice a week (BIW) during weeks 5-54, and once a month until week 62.

Blood, stool, saliva, bronchoalveolar lavage and nasal wash sample

Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy in Patients With Non-small Cell Lung Cancer

Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy

All possible pneumonitis events will be adjudicated by an expert committee including Dr. Altan, Dr. Sheshadri, an expert infectious disease doctor, and an expert thoracic radiologist. Logistic regression will be used to assess the association between the development of pneumonitis and covariates of interest. Will also use logistic regression to model the association between the development of immune checkpoint inhibitor (CPI)-related pneumonitis and separately the development of radiation related pneumonitis. Secondary analyses of the primary endpoint will include assessing the time to the development of pneumonitis. Cox regression models will be fit in a similar manner to assess the association with the same covariates.

Monitor home spirometry and symptoms to identify early pneumonitis. The MDASI is a brief (less than 5 minutes), psychometrically validated, multi-symptom assessment tool developed for use with cancer patients who are either undergoing or have completed cancer therapies. MDASI-immunotherapy will be administered weekly for the first 9 weeks of study, every two weeks from week 10 to week 54, and monthly until the end of study (week 62). If MDASI increases by 1, patients will be contacted to be evaluated for the possible development of pneumonitis, infection, or disease progression.

Home spirometry will measured forced lung function values such as vital capacity which will be monitored over time in study participants.

The development of treatment-emergent irAE overall and separately by type of AE will be summarized by the method of Kaplan and Meier. For AEs with enough events, may use Cox regression models to model the association with covariates of interest, including blood biomarkers.

Will assess the association between chemotherapy followed by immunotherapy and sleep quality by using the Pittsburgh Quality Sleep Index (PQSI).

Will assess the association between financial hardship as measured by changes in the Economic Strain and Resilience in Cancer survey and covariates of interest using linear regression.

Will be defined as an abnormal microbiome either measured orally or from the gut bacteria in the stool.

M.D. Anderson Cancer Center

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Cirrhosis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Fibrosis

cases are cirrhotic with hepatocellular carcinoma

pulmonary function tests using spirometry

spirometry

youssef Mohammed mahmoud, Resident

mahmoud saif Al-Islam, Professor

Magdy M Amin, Professor

Cirrhosis is a terminal image of chronic liver disease. During the progression from the compensation period to the decompensation period, various complications occur, and the life prognosis is significantly reduced. In recent years, medical treatment for liver cirrhosis has made marked progress. Liver cirrhosis may occur as an end result of manifold infectious, toxic, metabolic, or autoimmune conditions such as viral hepatitis, alcoholism, non-alcoholic steatohepatitis, autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), or a variety of storage disorders such as hemochromatosis, Wilson's disease, and alpha-1-antitrypsin deficiency.

Worldwide, hepatocellular carcinoma (HCC) is a universal problem and its epidemiological data showed variation from place to place. HCC represents the sixth most common cancer worldwide. In Egypt, it represents the fourth common cancer. Egypt ranks the third and 15th most populous country in Africa and worldwide, respectively. HCC is a commonly diagnosed cancer in males and females. It can lead to multi-organ failure including the respiratory system.

Pulmonary function tests (PFTS) are important as an investigation and monitoring of patients with respiratory pathology. They provide important information relating to the large and small airways, the pulmonary parenchyma, and the size and integrity of the pulmonary capillary bed. Although they do not provide a definite diagnosis, different patterns of abnormalities are seen in different respiratory diseases which help to establish the diagnosis.

Cirrhosis is a terminal image of chronic liver disease. During the progression from the compensation period to the decompensation period, various complications occur, and the life prognosis is significantly reduced. In recent years, medical treatment for liver cirrhosis has made marked progress. Liver cirrhosis may occur as an end result of manifold infectious, toxic, metabolic, or autoimmune conditions such as viral hepatitis, alcoholism, non-alcoholic steatohepatitis, autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), or a variety of storage disorders such as hemochromatosis, Wilson's disease, and alpha-1-antitrypsin deficiency .Worldwide, hepatocellular carcinoma (HCC) is a universal problem and its epidemiological data showed variation from place to place. HCC represents the sixth most common cancer worldwide. In Egypt, it represents the fourth common cancer. Egypt ranks the third and 15th most populous country in Africa and worldwide, respectively. HCC is a commonly diagnosed cancer in males and females. It can lead to multi-organ failure including the respiratory system.Patients with liver cirrhosis and HCC are vulnerable to many side effects that reduce their lifetime. One of these side effects is hypoxia resulting from Many conditions which can influence the gas exchange in the lungs. Ascites, pleural effusion, hepatomegaly, and basal lung lobes atelectasis are the most commonly identified causes and can disturb oxygen exchange in a restrictive manner. On the other hand, some side effects of cirrhosis such as hepatopulmonary syndrome or portopulmonary hypertension may make the prognosis worse.Pulmonary function tests (PFTS) are important as an investigation and monitoring of patients with respiratory pathology. They provide important information relating to the large and small airways, the pulmonary parenchyma, and the size and integrity of the pulmonary capillary bed. Although they do not provide a definite diagnosis, different patterns of abnormalities are seen in different respiratory diseases which help to establish the diagnosis.There is no simple mechanism to explain the association between liver disease and hypoxemia and there are probably many factors that have a role in its pathogenesis. Although none of them have been proven as the sole reason, nevertheless ascites, hepatopulmonary syndrome, low albumin levels, anemia, respiratory muscle weakness, and extreme hepatomegaly are still considered among the factors implicated in the pathogenesis of hypoxemia in cirrhosis .Pulmonary complications such as hepatopulmonary syndrome and pulmonary hypertension are observed frequently in these patients. The clinical picture characterized by hypoxemia in absence of primary heart and lung diseases in patients with liver failure is called hepatopulmonary syndrome. In hepatopulmonary syndrome, there is an increase in the alveolar-arterial oxygen gradient and a concomitant dilatation of the intrapulmonary vasculature during the inhalation of room air in addition to liver disease. Varying degrees of pulmonary findings including dyspnea, cyanosis, clubbing, and platypnea due to dilatations in the intrapulmonary vasculature (increase in dyspnea upon the shift from lying to standing position) and orthodeoxia (increase in hypoxia upon the shift from lying to standing position), and hypoxemia are seen in patients with HPS in cirrhotic and HCC patients.In general, PFT is employed to measure lung volumes, bronchial obstruction, gas exchange, lung compliance, and ventilatory capacity. Interstitial lung diseases (ILDs) are characterized by reduced lung volumes (restrictive ventilatory impairment), reduced (static) lung compliance, and reduced diffusing capacity. The pattern of lung function impairments does not allow a specific diagnosis to be made, but rather enables one to assess the presence or absence and the severity of lung involvement. Spirometry is a simple test to measure static lung volumes at rest-slow (inspiratory or expiratory) vital capacity (SVC), forced vital capacity (FVC)-and dynamic volumes-forced expiratory volume in 1 s (FEV1), flow-volume loops

Pulmonary Function Tests Study in Cirrhotic Patients With and Without Hepatocellular Carcinoma

assess pulmonary functions impairement and complications due to liver cirrhosis or HCC using spirometer device parameters.

Sohag University

Resident of Tropical medicine and gastroenterology department, Sohag University Hospitals

Respiration Disorders

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

patients receive one single dose of intravenous dexamethasone 8 mg.

patients receive one single dose of intravenous placebo.

One dose of intravenous dexamethasone (8 mg) 60 minutes before surgery.

Intravenous Dexamethasone

Patients of the control group received homologated placebo 60 minutes before surgery.

intravenous salin water

González-Ojeda Alejandro, PhD. MD.

Preoperative dexamethasone reduces symptoms after different surgical procedures including mastectomy in breast cancer, but the effect in the postoperative respiratory function remains unknown. The aim of this protocol was to determine if the administration of a single dose of dexamethasone during the preoperative, could improve respiratory function and postoperative symptoms of patients undergoing mastectomy in breast cancer.

Controlled clinical trial will be performed in 120 surgical patients treated for breast cancer, conducted from Nov 2014 to Nov 2015. Patients will be divided in three groups: Group 1 consisted in patients who underwent conservative breast with axillary lymph node dissection, group 2 in patients with radical mastectomy without reconstruction, and group 3 patients with radical mastectomy with immediate reconstruction with synthetic breast implants.

All patients will be randomly assigned by a system of sealed envelopes, to receive 8 mg of intravenous dexamethasone or placebo 60 minutes before surgery. All patients will be female and had a confirmed diagnosis of breast carcinoma. The investigators will exclude patients with a classification of the American Society of Anesthesiologists classes III and IV. Other exclusion criteria are: age 80 years, pregnancy or during menstruation, during steroid therapy, severe diabetes mellitus (serum HbA1c\> 8%); opioids, sedatives or painkillers less than a week before the mastectomy, or a history of alcohol or drugs. The investigators will exclude patients with a history of inner ear disease and / or severe PONV after any surgical procedure performed in the past. All patients will be admitted to hospital one day before surgery and were followed from hospital admission and until 30 days after surgery for any medical or surgical morbidity.

Anesthesia and surgery

All patients will be standardized to the next anesthetic protocol:

Under venipuncture, patients receive 1 g of Cephalothin IV one hour before starting the procedure. After entering the operating room, type 1 continuous monitoring was placed via noninvasive, Midazolam will be administered via peripheral 0.1-0.2 mg/kg as well as fentanyl 1 mcg / kg IV. Prongs will be placed and basal hemodynamic values will be taken with preoxygenation by tidal volume technique per minute.

Induction will be performed with Propofol 1-2 mg/kg IV and completed with fentanyl (3 mcg / kg IV) along with the administration of Rocuronium 0.06 mg/kg IV. Assisted oxygenation continues at a rate of 5 lpm and laryngeal mask (mask measure according to weight and body distribution of the patient) is placed.

During surgery, the medication will be completed with omeprazole 40 mg IV, Ondancetron 4 mg IV. All patients will be monitored with indirect determinations of blood pressure and heart rate using standard techniques, as well as the content of expired CO2 and oxygen saturation of the blood. Subsequently, all patients will be extubated and transferred to the unit for immediate post-surgical care with cardiovascular monitoring and oxygen.

Surgical Procedures All patients will be submitted to treatment according to the clinical stage with conservative breast surgery with axillary dissection, radical mastectomy without immediate reconstruction or radical mastectomy with immediate reconstruction with synthetic implants. In case of radical mastectomy, a closed drainage system will be placed in the chirurgic region, and will be removed when drainage is less than 50ml in 24 hours. Chemotherapy or radiation therapy will be administered 3-4 weeks following surgical resection.

Analgesic and antiemetic therapy Nonsteroidal antiinflammatory drugs will be used as analgesia after surgery with sodium ketorolac 30 mg IV every 6 hours (in patients younger than 60 years) or lysine Clonixinate 100 mg IV every 6 hours (in patients older than 60 years). Also, patients who will be submitted to a conservative surgery will receive intravenous Tramadol 100mg (diluted in 50ml of solution); the dose may be repeated every 12 hours until. Repeated doses of Morphine of 2.5 mg IV will be used in case of radical mastectomy, according to the needs of the patient. If pain is not diminish within 30 minutes a VAS will be used and in case the scale is greater than 7, an infusion of 10mg of morphine in 250ml 0.9% of saline solution will be used. Pain will be assessed on return to the recovery room and at 6, 12 and 24 h postoperatively using a visual analogue scale (VAS; 0 = no pain and 10 = most severe pain).

The incidence of PONV will be recorded immediately on return to the recovery room and at 6, 12 and 24 h postoperatively using a three-point ordinal scale (0 = asymptomatic, 1 = feeling of nausea or tonnage without expulsion oral route of gastric contents 2 = vomiting). Nausea is defined as a unpleasant sensation associated with awareness of the urge to vomit; retching is defined as the labored, spasmodic rhythmic contraction of the respiratory muscles without the expulsion of gastric contents, and vomiting is defined as the forceful expulsion of gastric contents from the mouth. Ondancetron will be used IV (4-8 mg) to treat these symptoms.

Pulmonary Function. To perform a spirometry, the ambient must comply the following characteristics: environment without audio or visual shocks and thermal comfort for the comfort of the patient. Patients will be told to sit in a comfortable position with your back straight (at an angle greater than 45°, to patient tolerance) and high chin. Lightweight support will be perform in the patient by taking her gently by the shoulders to keep them lean forward and off balance grew. In the immediate postoperative and due to postoperative pain, the patient will be settled in the stretcher to emulate the sitting position (inclination greater than 45 °) performing the previously mentioned subject. The nature of the study will be explained in understandable language to the patient, and their cooperation will be requested. Forced espiratory maneuver will be explained and immediately exemplified by the best qualified to understand the patient and to avoid measurement bias evaluator. Special emphasis will be placed on the importance of starting the effort with the maximum volume of air in the lungs, so determined and energetic, as well as maintaining exhalation as long as possible. She will be asked to take the disposable cardboard mouthpiece adaptable to pneumotachograph, sealing it with the lips in the position of maximal inspiration and then blow air through it, initiating a sharp exhalation maneuver with the above characteristics. To be a valid test, the maneuver should be performed with a proper effort, starting from the position of maximal inspiration without hesitation or false start with a continuous exhalation without corrections, cough or Valsalva maneuver, as well as checking for leaks were recorded in nozzle. A total of three satisfactory maneuvers will be performed with a maximum of eight attempts for each measurement, spaced at least for 30 seconds. To perform the study, a "Fleisch spirometer" with brand Sibelmed® neumotac type model will be used Datospir 110/120.

Measurements of forced espiratory volume in one second (FEV1), forced vital capacity (FVC) Maximum Forced Espiratory Flow (FEFM) and the ratio between forced espiratory volume in one second and forced vital capacity will be taken into account (FEV1 / FVC). Such clinical parameters are directly related to muscle fatigue, the compliance of the lung parenchyma and respiratory status of patients.

Statistical Analysis Postoperative complications will be recorded during hospitalization and patients will be followed up to 30 days after hospital discharge. Data collected will include patient age, body mass index (BMI), smoking history and neoadjuvant chemotherapy, anesthesia and operation time and the frequency of use of analgesics and antiemetics. These parameters will be added and compared between dexamethasone and placebo groups. The endpoints of the study will be postoperative nausea and vomiting, and pain measured by the VAS and the need for additional analgesia and antiemetic drugs as described.

The sample size was predetermined. The investigators expect a 35% difference in the incidence of nausea and vomiting between groups. The α error 0.05 and β error 0.20; n = 35 patients in each group will be considered adequate, according to an analysis of power. All results eill be expressed as percentages and means with standard deviation ± (SD). Student t test, Chi 2 of Fisher's exact test will be used to analyze quantitative and qualitative data, respectively. Differences will be considered statistically significant at p \<0.05.

Ethical Considerations This protocol has been registered with the Local Research and Ethics Committee on Health.

The study will be conducted according to the principles of the Helsinki Declaration of 1989, and with the Guidelines of Health of Mexico. The local research and ethics committee of Health Research Ethics Committees of the Cancer Institute of Jalisco, Mexico approved all protocols. A full written informed consent will be obtained from all patients before inclusion in the study.

Dexamethasone and Respiratory Function After Mastectomy

Effect of the Preoperative Administration of Dexamethasone in the Respiratory Function and Postoperative Symptoms in Women Undergoing Mastectomy for Cancer. Results of a Randomized Clinical Trial.

maximum amount of air a person can expel from the lungs after a maximum inhalation.

Measures the amount of air a person can exhale during a forced breath in one second.

An unpleasant sensation occurring in varying degrees of severity as a consequence of injury, disease, or emotional disorder.

Nausea is the feeling of having and urge to vomit. It is often called being sick to your stomach.

Vomiting is forcing the contents of the stomach up through the esophagus and out of the mouth.

Total dose of backup analgesic medication will be recorded during the last 24 hours after the surgical procedure.

Total dose of backup antiemetic medication will be recorded during the last 24 hours after the surgical procedure.

The prevalence of a disease in a particular percentage of the population; the number of cases of a particular disease per unit of population.

Determination of the oxygen saturation of arterial blood using an oximeter.

Instituto Mexicano del Seguro Social

Alejandro González-Ojeda, Ph.D., M.D.

Durvalumab

Patients will be enrolled after their treating physician has prescribed durvalumab and before they start durvalumab treatment. Patients will receive mobile and wearable devices alongside their durvalumab treatment without any additional interventions.

Using a spirometer, an armband, and a tablet to collect data.

Multiparametric Mobile Technology

A study of whether mobile devices can improve the detection of pulmonary AEs (including pneumonitis) in stage III NSCLC patients post-CRT, while on durvalumab.

Patients undergoing post-CRT treatment for lung cancer with consolidation durvalumab can experience pulmonary AEs that could become severe if not recognized and treated in time.

Data collected will be used to evaluate the likelihood of early detection of pulmonary AEs in unresectable Stage III NSCLC patients on durvalumab. This project seeks to understand if multiparametric mobile technology collecting patient reported outcomes, vital signs, and respiratory function, integrate well into a patients daily life and aid physicians in early detection of pulmonary AEs.

Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab.

Prospective, Interventional Pilot Study of Mobile Devices and Digital Applications to Detect Early Pneumonitis and Other Pulmonary Adverse Events in Unresectable Stage III Non-Small Cell Lung Cancer Patients on Durvalumab

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

An AE was occurrence of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product or device, whether or not considered causally related to the product or device medical occurrence in a participant. The TEAEs of pneumonitis were defined as any pneumonitis event that occurred or worsened at any time after the start of administration of the first dose of durvalumab and through 30 days after the last dose of durvalumab. Severity (intensity of any event) was assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events (CTCAE) v5. The AEs were assigned to a Grade from 1 through 5 as follows: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening requiring hospitalization; Grade 4: Life-threatening consequences; Grade 5: Death due to any AE.

Pulmonary TEAEs were defined as any pulmonary AEs that occurred or worsened at any time after the start of administration of the first dose of durvalumab and through 30 days after the last dose of durvalumab. Number of participants with permanent discontinuation of durvalumab due to pulmonary TEAEs including pneumonitis are reported.

The overall duration of durvalumab treatment, while participants were a part of this wearable study, was calculated as end date of durvalumab treatment minus first dose of durvalumab (Day 1) plus 1.

Number of participants who discontinued durvalumab early due to any reason are reported.

Treatment interruptions were defined as at least 1 temporary withholding of durvalumab treatment. Treatment withheld was defined as temporarily withheld of durvalumab recorded in case report form. Short interruptions defined as the durvalumab infusion interruption during the administration recorded in CRF in a single visit were excluded from the analysis. Due to data issue, the reason for treatment withheld was not captured in the database.

The overall duration of durvalumab treatment interruption was calculated as the sum of the duration of each treatment withheld/resumed. The duration of interruption included only treatment withheld. Short interruption which resumed during the same visit was not included in the calculation for duration of interruption.

Pulmonary TEAEs were defined as any pulmonary AEs that occurred or worsened at any time after the start of administration of the first dose of durvalumab and through 30 days after the last dose of durvalumab.

Pulmonary TEAEs were defined as any pulmonary AEs that occurred or worsened at any time after the start of administration of the first dose of durvalumab and through 30 days after the last dose of durvalumab. Duration of pulmonary TEAEs was calculated as end date of pulmonary TEAE minus onset date of pulmonary TEAE plus 1. For AEs that were missing an end date, the data cut-off date was used as the AE end date for calculation of AE duration.

Pneumonitis TEAEs were defined as any pneumonitis AEs that occurred or worsened at any time after the start of administration of the first dose of durvalumab and through 30 days after the last dose of durvalumab.

Duration of development of Grade 3 to 5 pneumonitis AEs is defined as the period from Day 1 to earliest of each grade of pneumonitis AE (grade 3, grade 4, and grade 5). Severity (intensity of an event) was assessed using the NCI-CTCAE v5. AEs were assigned to a Grade from 1 through 5 as follows: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening requiring hospitalization; Grade 4: Life-threatening consequences; Grade 5: Death due to any AE.

The EORTC QLQ-C30 consisted of 30 questions and included functional scales (FS) (items 1-7 and items 20-27), symptom scales (items 8-19 and item 28) and global measure of health status (GHS) (items 29-30). The scale ranged from 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much". Scores were averaged and transformed to 0 to 100, a high score for functional scales/GHS represented better functioning ability/QoL, whereas a high score for symptom scales represented stronger symptoms/worse QoL. Participants with pneumonitis TEAEs with causal relationship with durvalumab are presented. Time point 1: prior to occurrence of initial pneumonitis AE; Time point 2: at same time point as initial pneumonitis AE; Time point 3: when highest CTCAE grade of pneumonitis AE occurred. Baseline was defined as the date of informed consent for this parameter.

The EORTC QLQ-LC13 was a disease-specific 13-item questionnaire for lung cancer used in conjunction with the EORTC QLQ-C30. It comprised both multi-item and single-item measures of lung cancer associated symptoms (LCAS) (items 31-35 and items 40-42), treatment related side effects (TREF) (items 36-39) and pain medication (item 43). The scale ranged from 1-4 for most outcome measures of systems, 1 rated as "not at all" and 4 rated as "very much". Scores were averaged and transformed to 0 to 100, higher scores for LCAS and TREF: greater level of symptoms/worse QoL and higher scores for pain medication: better pain relief from medication. Participants with pneumonitis TEAEs with causal relationship with durvalumab are presented. Time point 1: prior to occurrence of initial pneumonitis AE; Time point 2: at same time point as initial pneumonitis AE; Time point 3: when highest CTCAE grade of pneumonitis AE occurred. Baseline was defined as the date of informed consent for this parameter.

AstraZeneca

The SAF included all enrolled participants who took at least 1 dose of durvalumab.

Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.

All Participants

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

The Safety Analysis set (SAF) included all enrolled participants who took at least 1 dose of durvalumab.

This pilot trial was terminated early due to the Coronavirus Disease-2019 (COVID-19) pandemic, shortage of site staff, and limited access to sites resulting in participant enrollment and retention challenges. The trial was not terminated early due to any safety concerns.

Global Clinical Lead

Grade 2

Grade 3

Number of Participants With Treatment-Emergent Adverse Event (TEAE) of Pneumonitis by Grade

Number of Participants With Permanent Discontinuation of Durvalumab Due to Pulmonary TEAEs

Duration of Durvalumab Treatment

Number of Participants With Early Discontinuation of Durvalumab

Number of Participants With Treatment Interruptions

Duration of Durvalumab Treatment Interruption

Number of Participants With Pulmonary TEAEs Excluding Pneumonitis

The SAF included all enrolled participants who took at least 1 dose of durvalumab. Only those participants with pulmonary TEAEs excluding pneumonitis were included in this analysis.

Duration of Pulmonary TEAEs Excluding Pneumonitis

The SAF included all enrolled participants who took at least 1 dose of durvalumab. Only those participants with pneumonitis TEAEs were analyzed.

Number of Participants Who Received Prescription Medication to Manage Pneumonitis TEAEs

Duration of Prescription Medication Received by Participants to Manage Pneumonitis TEAEs

Data was not collected due to early termination of the trial.

Duration of Development of Grade 3 to Grade 5 TEAEs, Including Pneumonitis

FS; Time point 1

FS; Time point 2

FS; Time point 3

Symptom scale; Time point 1

Symptom scale; Time point 2

Symptom scale; Time point 3

GHS; Time point 1

GHS; Time point 2

GHS; Time point 3

The SAF included all enrolled participants who took at least 1 dose of durvalumab. For each symptom scale, only those participants with data available were included in the analysis.

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) in Participants With Pneumonitis TEAEs

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Early Cancer Biomarkers in Breath Condensate in Population of Individuals With High-Risk of Lung Cancer Undergoing LDCT Screening.	NCT06016569	Lung Cancer	Exhaled breath ... Blood sampling LDCT Vital signs Spirometry	55 Years - 74 Years	The Institute of Molecular and Translational Medicine, Czech Republic
Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy in Patients With Non-small Cell Lung Cancer	NCT04913311	Lung Non-Small ...	Biospecimen Col... Bronchoscopy wi... Chemoradiothera... Computed Tomogr... Diagnostic Labo... Immune Checkpoi... Nasal Wash and ... Quality-of-Life... Questionnaire A... Spirometry	-	M.D. Anderson Cancer Center
Study of Early Cancer Biomarkers in Breath Condensate in Population of Individuals With High-Risk of Lung Cancer Undergoing LDCT Screening.	NCT06016569	Lung Cancer	Exhaled breath ... Blood sampling LDCT Vital signs Spirometry	55 Years - 74 Years	The Institute of Molecular and Translational Medicine, Czech Republic
Pulmonary Function Tests Study in Cirrhotic Patients With and Without Hepatocellular Carcinoma	NCT05963776	Pulmonary Compl...	spirometry	18 Years - 95 Years	Sohag University
Dexamethasone and Respiratory Function After Mastectomy	NCT02305173	Respiratory; Di...	Intravenous Dex... intravenous sal...	20 Years - 69 Years	Instituto Mexicano del Seguro Social
Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab.	NCT04381494	Unresectable St...	Multiparametric...	18 Years - 130 Years	AstraZeneca
Close Assessment and Testing for Chronic Graft Versus Host Disease, CATCH Study	NCT04188912	Hematopoietic a...	Biospecimen Col... Optical Coheren... Spirometry Survey Administ... Digital Photogr... Quality-of-Life... Medical Chart R...	18 Years -	Fred Hutchinson Cancer Center
Study of Early Cancer Biomarkers in Breath Condensate in Population of Individuals With High-Risk of Lung Cancer Undergoing LDCT Screening.	NCT06016569	Lung Cancer	Exhaled breath ... Blood sampling LDCT Vital signs Spirometry	55 Years - 74 Years	The Institute of Molecular and Translational Medicine, Czech Republic

Spots Global Cancer Trial Database for spirometry

Every month we try and update this database with for spirometry cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for spirometry

Every month we try and update this database with for spirometry cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for spirometry cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.