Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

People diagnosed with advanced lung cancer and scheduled to receive palliative RT will be invited to participate between 1st July 2019 and 31st January 2020.

Patients' family caregivers will also be invited to participate

Two questionnaires in patients and another two questionnaires in carer.

questionnaires

Saengrawee Thanthong

the purpose of this study is to investigate over time patients' symptom burden, caregiving burden, and patients and caregivers' need for information on patient symptom self-management at home during palliative radiotherapy(RT) for lung cancer. Repeatedly assessing burden and information needs on symptom self-management at home can help healthcare professionals to design a bespoke service and plan of care for both patients and family caregivers. In addition, I will explore psycho-social and clinical predictors of burden and information needs in patients and caregivers. These predictors can help health professionals to identify patients and caregivers at risk for distress during palliative radiotherapy for lung cancer.

Eligible patients will be invited to take part in the study via a patient information sheet. They will also be asked to nominate their primary caregiver, who will also be invited to take part in the study. We will give patients and caregivers 24 hours to decide whether they want to take part or not. If they do decide to take part, all research participants will be involved in the study on four consecutive occasions before, during and after their treatment. These four time points will be the following:

* before first fraction of RT
* 1st week of RT (1st-5th faction)
* 2nd week of RT (6th-10th fraction)
* 1 month after the last fraction of RT The principal researcher, i.e. Saengrawee Thanthong, will endeavour to collect questionnaires in the hospital. If participants cannot come to the hospital to receive radiotherapy or for their follow up appointment and complete the questionnaire, then the principal researcher will call them and offer to complete the questionnaires over the phone so as to minimise missing data due to attrition.

Descriptors and Predictors of Burden and Information Needs

Descriptors and Predictors of Burden and Information Needs on Symptom Self-management in Thai Patients With Lung Cancer and Their Family Caregivers During Palliative Radiotherapy

Measure by the Thai version of modified version of the Memorial Symptom Assessment Scale (MSAS)

information need on symptom self-management at home measure by The Supportive Care Needs Survey - Patient version (SCNS) (Bonevski et al., 2000\& McElduf et al., 2004) and Partners and Caregivers version (SCNS-P\&C) - Information needs subscale.

University of Glasgow

Chulabhorn Cancer Center

Principal Investigator

Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Neoplasm Metastasis

Thyroid Diseases

Thyroid Cancer, Papillary

Carcinoma, Papillary

Thyroid Neoplasms

Lymphatic Metastasis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Processes

Endocrine System Diseases

Neoplasms, Squamous Cell

Adenocarcinoma

Adenocarcinoma, Papillary

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Papillary Thyroid Carcinoma

Nine preoperative predictors were identified for the nomogram: gender, age, platelet counts, TPOAb level and US signatures including maximum diameter, boundary, component, calcification and cervical lymph node enlargement.

male

mingtong xu, professor

To establish and validate a suitable and practical nomogram for primary hospitals to predict the risk of central lymph node metastasis (CLNM) among thyroid papillary carcinoma (PTC) patients based on clinical and ultrasound characteristics among Chinese population，1000 PTC patients were retrospectively reviewed who underwent bilateral thyroidectomy or lobectomy plus central lymph node dissection（CLND） between June 2014 and September 2019 in Sun Yat-sen Memorial Hospital (Guangzhou, South China), and then LASSO regression analysis was performed to screen out the possible predictors. Another 200 PTC patients from the First Affiliated Hospital of Zhengzhou University (Zhengzhou, North China) who underwent bilateral thyroidectomy or lobectomy plus CLND between March 2019 and November 2020 were enrolled to construct the nomogram. The area under the receiver operating characteristic (ROC) curves (AUC), calibration curves and decision curve analysis (DCA) were used to evaluate the nomogram.

1000 Patients who underwent total thyroidectomy or lobectomy and were diagnosed as PTC by pathological examination between June 2014 and September 2019 in Sun Yat-sen Memorial Hospital (Guangzhou, South China) and 200 patients in the First Affiliated Hospital of Zhengzhou University (Zhengzhou, North China) from March 2019 to November 2020 were selected as the subjects to construct the nomogram. 1000 patients were randomized at 7:3 and divided into a training set and a verification set. Besides, 200 cases that met the inclusion and exclusion criteria above-mentioned in the First affiliated Hospital of Zhengzhou University were enrolled as a external verification set.

The following clinical features for each patient were obtained before surgery: gender, age, occupation, complicated with autoimmune diseases (absent / present), history of radiation exposure (absent / present), family history of thyroid cancer (absent / present), with other tumors (absent / present) and preoperative laboratory examinations including neutrophil count, lymphocyte count, platelet count, thyroid-stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), anti-thyroglobulin antibody (TgAb), thyroid peroxidase antibody (TPOAb).

Preoperative US signatures of thyroid tumors were also included: distribution (unilateral / bilateral), shape (regular / irregular), maximum diameter, number (single / multiple), boundary（clear /heliclear / unclear), component (solid /cystic-solid), calcification (absent / microcalcification / macrocalcification), blood flow (absent / internal / annular), cervical lymph node enlargement (absent / present).

A nomogram were established for predicting CLNM based on the universally available baseline Characteristics of PTC patients at a tertiary hospital in South China and externally validate it with data from North China. Odd ratios (ORs), 95% confidence interval (CI) and probability values were obtained by logistic regression analysis. The area under the receiver operating characteristic (ROC) curve (AUC) was calculated to evaluate the accuracy of the nomogram for predicting CLNM. The calibration curve and Hosmer-Lemeshow tests were performed to evaluate the calibration of the nomogram. The decision curve analysis (DCA) was applied to validate clinical utility of the nomogram.

A Nomogram Model to Predict Central Lymphnode Metastasis in Thyroid Papillary Carcinoma

A Nomogram Model to Predict Central Lymphnode Metastasis in Thyroid Papillary Carcinoma Suitable for Primary Hospitals

Multivariate logistic regression analysis were conducted to determine the potential nonlinear association between predictors and and the risk of CLNM.

The First Affiliated Hospital of Zhengzhou University

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

All Drugs and Chemicals

Immunomodulating Agents

Lingxiang Liu, MD

This is a retrospective clinical study aimed at observing and evaluating the effectiveness and safety of checkpoint inhibitors in the treatment of patients with solid tumors in actual clinical applications. To explore predictors of efficacy patients with unresectable solid tumors receiving checkpoint inhibitors and develop and further validate predictive models.

The clinical data of patients with unresectable solid tumors were collected retrospectively, who received two or more cycles of checkpoint inhibitor therapy. The progression-free survival (PFS), overall survival (OS) and related adverse reactions of the patients were followed up. To screen prognostic factors, develop predictive models and visualize them as nomograms.

Checkpoint Inhibitors in Patients With Solid Tumors: a Retrospective Real-world Study

ORR is defined as the percentage of patients achieving complete response and partial response.

DCR is defined as the percentage of patients achieving complete response, partial response and stable disease.

AE includes abnormalities in clinical symptoms, vital signs and laboratory tests.

PFS is defined as the time from initiation of checkpoint inhibitors until disease progression or death, whichever comes first.

OS is defined as the time from initiation of checkpoint inhibitors to death or last follow-up.

The First Affiliated Hospital with Nanjing Medical University

Jianfei Tu, Dr

Jingjing Song, Dr

This study is a retrospective, multicenter clinical study. The main goal is to identify the risk factors for cavity formation in central-type lung cancer lesions, and to construct a prediction model for cavity formation in central-type lung cancer lesions based on the above risk factors.

Independent Predictors Analysis and Model Construction of Cavitary Central Lung Cancer

Independent Predictors Analysis and Model Construction of Cavitary Central Lung Cancer: a Retrospective, Multicenter Trial

Statistical analysis plan, informed consent form, and clinical study report can be shared with other researchers.

Time from enrollment to the time of cavities formation, assessed up to 18 months.

Time from enrollment to hemoptysis, assessed up to 18 months.

The First Affiliated Hospital of Soochow University

The Second Affiliated Hospital of Medical College of Zhejiang University

Affiliated Hospital of Xinjiang Medical University

The Central Hospital of Lishui City

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

Amino Acids

Dasatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.

Fresh frozen tumor tissue must be available prior to initiating dasatinib. Eligible patients will receive neoadjuvant dasatinib 70 mg PO twice daily for 3 weeks followed by surgery. The surgical specimen will be evaluated for pathologic response. The second tumor sample will be obtained after 3 weeks of dasatinib therapy at the time of definitive surgical resection which will be evaluated for changes in genomic expression profiles. Patients with at least a 15% decrease or better objective response, without evidence of progression (per tumor evaluation pre-surgery) or pathologic response (as defined as ≥30% tumor necrosis or cell death) to neoadjuvant dasatinib therapy will be eligible to receive dasatinib 70 mg twice daily for 90 days after the completion of standard adjuvant therapy.

Neal Ready, M.D.

Src expression has been identified in a majority of Non-Small Cell Lung Cancer (NSCLC) cell lines and there is preclinical evidence that Src family kinases may be important in hypoxic growth and angiogenesis in NSCLC. We hypothesize that the inhibition of Src pathway with dasatinib will demonstrate anti-tumor activity in early stage NSCLC, with a tolerable safety profile.

Patients will receive dasatinib, a Src inhibitor, for 3 weeks prior to surgical resection for early stage NSCLC. Fresh frozen tumor tissue is needed for genomic analysis. If fresh frozen tumor tissue is not available from the initial diagnosis, a biopsy will be required to participate in this trial. A second tumor sample will be obtained at time of surgical resection to evaluate for changes in genomic expression profiles.

Patients will be eligible to receive 3 months of adjuvant dasatinib therapy after completion of standard adjuvant therapy or after recovery from surgery if no standard adjuvant therapy is given, if there is evidence of neoadjuvant tumor response (radiologic and/or pathologic) to dasatinib.

Many patients who present with NSCLC are active smokers. Patients who are smoking up until the time of their surgery experience increased peri-operative complications compared to patients who have not smoked cigarettes immediately prior to surgery. While this trial will not be limited to active smokers, the period of smoking cessation prior to surgery is an attractive window of opportunity during which the potentially active novel anticancer therapy dasatinib can be offered to the patient.

This is a phase II study of dasatinib, a targeted biologic agent, known to inhibit Src. It is difficult to assess outcome in phase II adjuvant trials because there is no measurable disease to evaluate efficacy and there are many variables that could confound comparing survival of subjects on trial to historical controls. Therefore, after a fresh frozen tumor tissue sample is obtained for genomic analysis, we plan to treat subjects with neoadjuvant dasatinib and then measure tumor response to therapy prior to surgery. Resected tumor will also be assessed for pathologic response as well as for changes in genomic expression patterns.

Subjects will be treated with neoadjuvant dasatinib 70 mg PO twice daily for 3 weeks, with a mandatory minimum of 3 days (72 hours) off of study drug prior to surgical resection. Imaging studies will be done pre-treatment and pre-surgery to assess radiologic response to therapy. The surgical specimen will be evaluated for pathologic response. A tumor tissue sample will be obtained from the surgical specimen for genomic analysis and will be evaluated for changes in genomic expression profiles.

Patients whose tumors have a response to neoadjuvant dasatinib therapy might benefit with better cancer control if they receive a potentially therapeutic course of adjuvant dasatinib. Patients that have at least a 15% decrease or better objective response, without evidence of progression to neoadjuvant dasatinib (per tumor evaluation pre-surgery) or pathologic response (as defined as ≥30% tumor necrosis or cell death) to neoadjuvant dasatinib therapy will be eligible to receive dasatinib 70 mg twice daily for 90 days after the completion of standard adjuvant therapy or after recovery from surgery if no standard adjuvant therapy is given. Patients will be followed for approximately 30 days after the last dose of dasatinib to assess toxicity.

Response will be evaluated in Src regulated and Src deregulated cohorts of tumors. If responses to neoadjuvant dasatinib occur, then accrual to either or both cohorts will be expanded. If there are no responses to neoadjuvant dasatinib in the cohort groups, then accrual to either or both cohorts will be stopped. The results of this study may be useful in designing future studies in early stage NSCLC using dasatinib alone or in combination with chemotherapy.

Phase II Study Evaluating The Safety And Response To Neoadjuvant Dasatinib In Early Stage Non-Small Cell Lung Cancer

Phase II Study Evaluating The Safety And Response To Neoadjuvant Dasatinib In Early Stage Non-Small Cell Lung Cancer (NSCLC).

Response rate (radiologic and pathologic) in Stage IB and II to neoadjuvant dasatinib

Determine the safety and tolerability of neoadjuvant dasatinib in early stage NSCLC.

Determine whether gene expression profile activation of Src pathways is correlated with anti-tumor activity of dasatinib in early stage NSCLC.

Determine the safety and tolerability of adjuvant dasatinib in early stage NSCLC.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Descriptors and Predictors of Burden and Information Needs	NCT04069494	Advanced Lung C... Symptoms	questionnaires	18 Years -	Chulabhorn Cancer Center
A Nomogram Model to Predict Central Lymphnode Metastasis in Thyroid Papillary Carcinoma	NCT05191927	Thyroid Papilla...	male	-	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Checkpoint Inhibitors in Patients With Solid Tumors: a Retrospective Real-world Study	NCT05719324	Immunotherapy		18 Years -	The First Affiliated Hospital with Nanjing Medical University
Independent Predictors Analysis and Model Construction of Cavitary Central Lung Cancer	NCT05278754	Central Lung Ca...		18 Years -	The Central Hospital of Lishui City
Phase II Study Evaluating The Safety And Response To Neoadjuvant Dasatinib In Early Stage Non-Small Cell Lung Cancer	NCT00564876	Carcinoma, Non-...	Dasatinib	18 Years -	Duke University
Checkpoint Inhibitors in Patients With Solid Tumors: a Retrospective Real-world Study	NCT05719324	Immunotherapy		18 Years -	The First Affiliated Hospital with Nanjing Medical University

Spots Global Cancer Trial Database for predictor

Every month we try and update this database with for predictor 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 predictor

Every month we try and update this database with for predictor 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 predictor 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.