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Trial Title:
Lung Cancer Biomarkers and Screening
NCT ID:
NCT00301119
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
small cell lung cancer
non-small cell lung cancer
smoker lung cancer screening
low dose spiral CT screening
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
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.
Detailed description:
OBJECTIVES:
- 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.
Criteria for eligibility:
Study pop:
healthy subjects at risk for lung cancer and controls from community, private physician
referrals, local trade unions, employee health fairs, word of mouth and print
advertisements.
patient referrals from physician outpatient offices and inpatients with CT findings
suspicious for lung cancer.
Sampling method:
Non-Probability Sample
Criteria:
DISEASE CHARACTERISTICS:
- Screening Cohort
- At high- or low-risk for lung cancer
- Smoking history ≥ 20 pack years*
- With or without workplace exposure to asbestos
- NOTE: * Participants with < 20 pack years of smoking are eligible if 50 years of age
or older
- Rule-Out Lung cancer group
- Referred for evaluation of suspicious nodules with 1 of the following
diagnoses:
- Lung cancer
- Nonmalignant nodules (control group)
PATIENT CHARACTERISTICS:
- Not pregnant
- No prior malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
- Not specified
Gender:
All
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
NYU Cancer Institute at New York University Medical Center
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
James J. Tsay, MD, MSc
Phone:
212-598-6351
Email:
Jun-Chieh.Tsay@nyulangone.org
Start date:
May 2000
Completion date:
May 2030
Lead sponsor:
Agency:
NYU Langone Health
Agency class:
Other
Source:
NYU Langone Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00301119
