Lung Cancer Biomarkers and Screening (NYULCBC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00301119|
Recruitment Status : Recruiting
First Posted : March 10, 2006
Last Update Posted : March 15, 2022
RATIONALE: Screening tests that use biomarkers may help doctors find tumor cells early and plan effective treatment for lung cancer.
PURPOSE: This clinical trial is studying biomarkers in screening participants for lung cancer.
|Condition or disease|
- Identify and validate biomarkers for the early detection of lung cancer in individuals at low- or high-risk for smoking-related cancers.
- Identify preneoplastic cellular changes and lesions in these patients.
OUTLINE: Participants are stratified according to lung cancer risk status (with or without increased risk).
Group 1 (screening cohort): Participants complete a questionnaire and undergo pulmonary function testing, multidetector chest CT scan, sputum induction, and phlebotomy.
Group 2 (rule-out lung cancer): Participants complete the same questionnaire and undergo the same tests and scans as in group 1. Some participants may undergo fiberoptic bronchoscopy based upon CT scan results with transbronchial or endobronchial biopsies. Some participants may undergo lung resection. Tissue samples are collected from surgery or biopsy.
PROJECTED ACCRUAL: A total of participants will be accrued for this study.
|Study Type :||Observational|
|Estimated Enrollment :||6860 participants|
|Official Title:||NYU Lung Cancer Biomarker Center|
|Study Start Date :||May 2000|
|Estimated Primary Completion Date :||May 2030|
|Estimated Study Completion Date :||May 2030|
lung cancer screening cohort
observational only. no intervention. current, former and never smokers over age 50 without history of cancer, except for non melanoma skin cancer, no previous treatment with chemotherapy.
r/o lung cancer
observational only. no intervention. patients with CT findings suspicious for lung cancer who are undergoing bronchoscopy and/or surgery.
- Lung cancer diagnosis as measured by CT scan findings and pathology findings annually [ Time Frame: 07/01/2015 ]
- Precancerous lung nodules as measured by CT scan findings and pathology findings annually [ Time Frame: 07/01/2015 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301119
|Contact: James N Tsay, MD, MPH||212-598-6351||Jun-Chieh.Tsay@nyulangone.org|
|Contact: Ellen M Eylers, RN, MSN, MPHfirstname.lastname@example.org|
|United States, New York|
|NYU Cancer Institute at New York University Medical Center||Recruiting|
|New York, New York, United States, 10016|
|Contact: William N. Rom, MD, MPH 212-263-6479 email@example.com|
|Principal Investigator:||James N. Tsay, MD||NYU Langone Health|