Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Adenocarcinoma

Lung Neoplasms

Adenocarcinoma of Lung

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Lung Adenocarcinoma

CT surveillance, Lung biopsy, Lung resection

CT scans

Lung cancer is one of the most common cancers in the Singapore population, being the 2nd most commonly diagnosed cancer amongst males and 3rd most commonly diagnosed cancer amongst females. Pulmonologists, oncologists and thoracic surgeons are often consulted for the evaluation of imaging-identified pulmonary nodules. These may have been identified either incidentally or through screening. The majority of these are indeterminate and definitive investigation with biopsy or resection is invasive and not without risk. Hence, current consensus guidelines adopt a largely expectant strategy in the management of these indeterminate pulmonary nodules.

There is substantial evidence that lung cancer in Asians may be unique with multiple driver mutations, lower age of presentation and may be independent of tobacco exposure. In addition, there are guidelines that recommend that the management of lung nodules in Asia should account for these differences. However, the evidence for alternative recommendations is lacking.

The aim of the study will be to identify radiological and clinical predictors that can improve the diagnosis of lung nodules. These predictors may help build a model for lung nodule evaluation and surveillance.

Prospective database of subjects meeting all of the following inclusion criteria to participate in this study.

1. Evidence of lung nodule on chest radiograph or Computed Tomography regardless of underlying aetiology
2. Age ³ 21 years old
3. Ability to provide informed consent This study will collect existing or prospective data that is part of standard clinical care from the electronic medical record of patients (ambulatory and inpatient from May 2018-2023.

1. BACKGROUND AND RATIONALE

   Lung cancer is one of the most common cancers in the Singapore population, being the 2nd most commonly diagnosed cancer amongst males and 3rd most commonly diagnosed cancer amongst females. Pulmonologists, oncologists and thoracic surgeons are often consulted for the evaluation of imaging-identified pulmonary nodules. These may have been identified either incidentally or through screening. The majority of these are indeterminate and definitive investigation with biopsy or resection is invasive and not without risk. Hence, current consensus guidelines adopt a largely expectant strategy in the management of these indeterminate pulmonary nodules.

   There is substantial evidence that lung cancer in Asians may be unique with multiple driver mutations, lower age of presentation and may be independent of tobacco exposure. In addition, there are guidelines that recommend that the management of lung nodules in Asia should account for these differences. However, the evidence for alternative recommendations is lacking.
2. HYPOTHESIS AND OBJECTIVES

   The aim of the study will be to identify radiological and clinical predictors that can improve the diagnosis of lung nodules. These predictors may help build a model for lung nodule evaluation and surveillance.
3. EXPECTED RISKS AND BENEFITS

   There are likely to be no benefits to subjects. They will not be subject to any novel therapy and their clinical/radiological data will only be collected.

   Risks are minimal because patients are subject to only standard diagnostic work-up and existing clinical data collected. There will be no new additional interventions, consultations or hospital visits. They will be asked to complete validated quality of life surveys that will be included into the clinical record.
4. STUDY POPULATION

   4.1. List the number and nature of subjects to be enrolled.

   Patients will only be enrolled from those who present to Singapore General Hospital, National Cancer Centre, National Heart Centre, Changi General Hospital and Sengkang General Hospital (either in an ambulatory or inpatient setting). There is no exclusion of women or minorities. Children are excluded because lung nodule detection in them is rare and the pathological processes, as well as clinical considerations are different.

   4.2. Criteria for Recruitment and Recruitment Process

   Subjects will be recruited if they already have radiographic evidence of a lung nodule.

   4.3. Inclusion Criteria

   The subject must meet all of the following inclusion criteria to participate in this study.
   1. Evidence of lung nodule on chest radiograph or Computed Tomography regardless of underlying aetiology
   2. Age \> 21 years old
   3. Ability to provide informed consent

   4.4. Exclusion Criteria Subjects who no radiographic evidence of lung nodules or who are unwilling/unable to provide informed consent
5. STUDY DESIGN AND PROCEDURES/METHODOLOGY

   This study will collect existing or prospective data that is part of standard clinical care
   * Source of the data: electronic medical record of patients (ambulatory and inpatient)
   * Data will be collected prospectively.
   * Time period: May 2018-2023
   * When subject collection is complete, the data will be de-identified and kept in an electronic database
   * Only principal investigator and co-investigators will have access to collected information.
   * Data be kept for 6 years after completion of study for data analysis and manuscript preparation
   * All electronic copies of data will be destroyed at the end of the study. All manual records if any will be shredded.

   Data that will be collected
   * Demographic data such as age, gender, ethnicity, ambulatory/inpatient setting
   * Clinical data including co-morbidities, medication history, American Society of Anaesthesiologists (ASA) status, smoking history, functional status (eg ECOG),
   * Risk factors such as BMI, exercise intensity, previous malignancy, radiation exposure, 2nd hand cigarette exposure, Family history of cancer, asbestos/environmental exposure
   * Radiographic data including nodule size, location and characteristics (borders, density, calcification, cavitation thickness), fibrosis, adenopathy
   * Laboratory data including LDH, glucose, albumin, total protein; Full blood counts, Renal panel, Liver Panel, Coagulation studies
   * Histopathology and microbiology results
   * Procedure details: designation of operator, procedure duration, anaesthesia used, complications, number of biopsies taken, size of specimen, location of procedure, use of anti-microbials

   Subjects may withdraw voluntarily from participation in the study at any time. They will have standard care as indicated by the managing physician
6. SAFETY MEASUREMENTS 6.1. Definitions

   An adverse event (AE) is any untoward medical occurrence that occurs as a result of the study. This will reported to CRIB.

   6.2. Collecting, Recording and Reporting of Adverse Events and Serious Adverse Events to CIRB

   PI will be responsible for submitting to the approving CIRB the completed serious AE Reporting Form within 7 calendar days after the investigator is aware of the event, followed by a complete report within 8 additional calendar days. AE that are related events should be reported at least annually (together with Study Status Report for annual review).

   6.3. Safety Monitoring Plan

   Not applicable. Current standard investigations and treatment to be provided to all subjects.

   6.4. Complaint Handling

   Complaints about the study will be escalated to the clinical Head of Department and included in reports to the CIRB.
7. DATA ANALYSIS

   7.1. Data Quality Assurance

   Data collection will be done by the investigators through the clinical team managing the patient to ensure completion and accuracy.

   7.2. Data Entry and Storage
   * Data will be entered and stored in a secure web application (REDCap)/password controlled hospital computer. When subject data collection is complete, the data will be de-identified and kept in an electronic database (password secured) for analysis. Only investigators will have access to the data.
   * There are no plans to keep any documentation of patients beyond the informed consent forms. These will be stored in the locked department office of the investigators.
8. SAMPLE SIZE AND STATISTICAL METHODS

   8.1. Determination of Sample Size

   The sample size is determined by the number of patients accrued into the database during the study period. As this is a non-comparative study, study size calculation not applicable.

   8.2. Statistical and Analytical Plans
   * Continuous safety analyses tracking for AE
   * Interim Analyses of data on an annual basis
9. DIRECT ACCESS TO SOURCE DATA/DOCUMENTS

   The CRIB will be permitted to audit the database as needed. Source documents are from electronic medical records.
10. QUALITY CONTROL AND QUALITY ASSURANCE

    Data collection will be done by the investigators through the clinical team managing the patient to ensure completion and accuracy.
11. ETHICAL CONSIDERATIONS

    11.1. Informed Consent

    Informed consent will be sought from the patient or legal guardian (in the case of minors) by the study investigators before any data collection is done.

    11.2. Confidentiality of Data and Patient Records
    * Data will be entered and stored in a secure web application (REDCap)/password controlled hospital computer. When subject data collection is complete, the data will be de-identified and kept in an electronic database (password secured) for analysis. Only investigators will have access to the data.
    * There are no plans to keep any documentation of patients beyond the informed consent forms. These will be stored in the locked department office of the investigators.
12. PUBLICATIONS

    Investigators will be involved in authorship depending on the degree of contribution.
13. RETENTION OF STUDY DOCUMENTS

    Study documents will be retained for 6 years after the end of the study in a locked department office and hospital computer that is password protected.
14. FUNDING and INSURANCE

This study has no funding.

Lung Nodule Prospective Database

Singapore General Hospital

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Carcinoma, Bronchogenic

Bronchial Neoplasms

Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA)

Tissue sample collected bronchoscope using needle aspirate of lung lymph gland, procedure takes 1 hour.

EBUS-TBNA

George A. Eapen, M.D.

The goal of this clinical research study is to learn how accurately an endobronchial ultrasound transbronchial needle aspiration (EBUS -TBNA) may detect mediastinal lymph node metastases in patients with clinical stage I and II non-small cell lung cancer (NSCLC).

Study Procedures:

A procedure called EBUS-TBNA has been developed that might allow doctors to get samples of lymph glands without performing an operation. The standard practice is a surgical operation called a mediastinoscopy. If researchers find out that EBUS-TBNA is as accurate as mediastinoscopy, it may mean that patients with lung cancer can avoid having surgery or will be able to get treatment before surgery.

EBUS-TBNA:

If you agree to take part in this study, you will first have an EBUS-TBNA. This will be performed on an out-patient basis under general anesthetic. The doctor will examine your lungs for suspicious lymph glands with an ultrasound, and then will take a sample of tissue from the lymph gland. This will be done using a flexible scope called a bronchoscope that can be passed into the windpipe. The lymph glands around the wind pipe can be seen and then removed with a small needle. The procedure should take about 1 hour.

Researchers will then analyze the lymph glands that were removed. Depending on whether or not the lymph glands have cancer in them, your doctor will then recommend the most appropriate therapy for you. This may include mediastinoscopy or some other appropriate therapy.

All the data for the study will be stored with a password protected system.

Length of Study:

Your participation in this study will be over after you have completed EBUS-TBNA.

This is an investigational study. EBUS-TBNA is FDA approved for this procedure.

Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.

Utility of Endobronchial Ultrasound Guided Needle Biopsy in Early Stage Non- Small Cell Lung Cancer (NSCLC)

Diagnostic Utility of Endobronchial Ultrasound Guided Mediastinal Lymph Node Sampling in Clinical Stage I and II Non Small Cell Lung Cancer

False negative rate estimated using EBUS guided mediastinal lymph node biopsy following a negative positron emission tomography (PET) scan with a 90% credible interval.

M.D. Anderson Cancer Center

CT scan performed weekly to measure how much the tumor moves + additional pulmonary function measurements.

CT Scans

Implanted radio-opaque fiducial markers, diameter of 1.0 - 2.0 mm, inserted through a catheter at several chest locations using a flexible bronchoscope

Implanted markers

Radiotherapy incorporating respiratory treatment delivery

Radiation Treatment (RT)

George Starkschall, PhD

Objectives:

* To determine the safety of fiducial implantation.
* To determine the extent/rate of migration of radio-opaque fiducials placed in lung tumors and adjacent normal tissue.
* To compare real-time portal imaging-based fiducial tracking with measurement of three-dimensional motion by four-dimensional CT scanning to determine how many fiducials are needed to track a tumor.
* To determine if intra-fractional lung tumor motion changes during a course of treatment, and when during the treatment this occurs.
* To correlate the position of internal fiducials with the position of the external patient surface during respiration.
* To quantify the residual motion of the clinical target volume during radiotherapy gated using external fiducials.
* To verify the adequacy of the treatment portal margins in encompassing the residual motion of the clinical target volume.
* To determine if radio-opaque fiducial placement adjacent to the trachea (which does not move) can reduce daily setup inaccuracies, and so spare normal tissue.
* To determine the motion of hilar adenopathy (if any), and whether it correlates with motion of the primary tumor.

If you are eligible to take part in this study, you will have pulmonary (lung) function testing. This testing will involve your breathing through a mouthpiece and measuring the amount of air you breathe. This will provide information on how well your lungs work, and how your chest wall moves when you breathe.

You will then begin the normal treatment planning process. A bean-bag "cast" will be made for you to lie in during planning and treatment. This is done to lower day-to-day changes in your position. A CT scan will be taken with you breathing quietly, and possibly several X-rays will be performed as well. You will be marked with magic marker, and possibly have several permanent tattoos placed to help with daily positioning. These procedures normally take 1-2 hours.

Small metal markers (up to 5) will then be placed near your tumor. A thin, flexible tube with a camera, called a bronchoscope, will be used to place these markers in your lungs. You will be given a sedative through one of your veins and a local anesthetic will be sprayed in your nose and mouth before introducing the bronchoscope. The bronchoscope is introduced through one of your nostrils and then passed into your windpipe and bronchial tubes. This will allow the doctor to examine your lungs and place the small metal markers. These markers will be used to track the tumor during treatment. In this way the radiation treatment can be given to the tumor even if it moves while you breathe.

You will also have studies to measure how much the tumor moves. This will be done with several additional CT scans, typically taken on a weekly basis. Additional pulmonary function measurements will be taken during the CT scans. These measurements will allow researchers to monitor the movement of your tumor when you breathe. These procedures will normally take between 1 and 2 hours.

You will be on this study for the duration of your radiation treatments. You will be followed up an for an additional 4 - 6 weeks to make sure there are no complications from the study.

THIS IS AN INVESTIGATIONAL STUDY. A total of up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.

Tracking of Respiratory-Induced Tumor Motion Using Implanted Fiducials

Assessment of the Reliability of Implanted Fiducials for Tracking of Respiratory-Induced Tumor Motion

Heart and Blood Diseases

Thromboembolism

Venous Thromboembolism

Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

Prevalence of unsuspected VTE in oncology patients on routine staging CT scans of the thorax, abdomen and pelvis

Survey tools and VTE Symptom Follow-up Questionnaire

Questionnaires

Carmen Escalante, MD

This is a prospective study with the following objectives:

Primary Objective:

1. To estimate the prevalence of unsuspected VTE in oncology patients on routine staging CT scans of the thorax, abdomen and pelvis.

   Secondary Objectives:
2. To identify symptoms commonly associated with VTE that are present in cancer patients undergoing routine staging CT scans with findings of unsuspected VTE.
3. To identify the risk factors and demographic characteristics in outpatient cancer patients associated with the development of unsuspected VTE.
4. To determine the incidence of recurrence of new VTE in patients with unsuspected VTE at 3 and 6 months of follow-up.

Patients diagnosed with cancer are routinely scheduled for staging CT scans. The CT scans are obtained to stage a new cancer diagnosis, to restage a cancer after treatment initiation or to evaluate abnormal masses, disease progression or metastasis. The study population will include outpatients scheduled for routine CT scan of the chest, abdomen and/or pelvis.

While patients are waiting in the Diagnostic Imaging waiting area, they will be invited to participate in the study. Study eligibility will be determined by administering a screening questionnaire. Cancer patients who meet the eligibility criteria will be asked to participate in the study. It is imperative that the patient completes the surveys and not the caregiver. A caregiver may lend assistance in transcribing the information but may not complete the instruments independent of the patient.

Many of these tools are brief and the estimated completion time should be approximately 15 to 30 minutes. Additionally completing the instruments will not extend beyond the time the patient is in the CT scan waiting area prior to the scheduled study.

On the day of study enrollment, patients will be asked to complete Brief Fatigue Inventory (BFI), MD Anderson Symptom Inventory (MDASI), Dyspnea Numerical Scale (DNS), Cancer Dyspnea Scale (CDS), ECOG/Zubrod Performance scale, Depression Anxiety Stress Scale (DASS 21), VTE Symptom Enrollment Questionnaire and Functional Assessment of Cancer Therapy-General (FACT-G). The patients will also complete a questionnaire on symptoms of VTE such as chest pain, pain or swelling of the extremities and other common symptoms reported in VTE patients.

VTE Symptom Follow-up Questionnaire:This instrument was designed for this study. Patients will be asked at 3 and 6 months the treatments received, recurrence of VTE, incidence of bleeding episodes and other health related conditions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lung Nodule Prospective Database	NCT03922828	Lung Neoplasms Lung Cancer Lung Adenocarci...	CT scans	21 Years - 120 Years	Singapore General Hospital
Utility of Endobronchial Ultrasound Guided Needle Biopsy in Early Stage Non- Small Cell Lung Cancer (NSCLC)	NCT00832715	Lung Cancer	EBUS-TBNA	18 Years -	M.D. Anderson Cancer Center
Tracking of Respiratory-Induced Tumor Motion Using Implanted Fiducials	NCT00500513	Lung Cancer	CT Scans Implanted marke... Radiation Treat...	-	M.D. Anderson Cancer Center
Cancer Patients Diagnosed With Unsuspected Venous Thromboembolism (VTE) on Routine Computed Tomography (CT) Scans	NCT00925808	Cancer Venous Thromboe...	Questionnaires	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for ct scans

Every month we try and update this database with for ct scans 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 ct scans

Every month we try and update this database with for ct scans 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 ct scans 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.