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NYULCBC: Lung Cancer Biomarkers and Screening

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT00301119
Collaborator
(none)
6,860
Enrollment
1
Location
360
Duration (Months)
19.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    6860 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    NYU Lung Cancer Biomarker Center
    Study Start Date :
    May 1, 2000
    Anticipated Primary Completion Date :
    May 1, 2030
    Anticipated Study Completion Date :
    May 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Lung cancer diagnosis as measured by CT scan findings and pathology findings annually [07/01/2015]

    Secondary Outcome Measures

    1. Precancerous lung nodules as measured by CT scan findings and pathology findings annually [07/01/2015]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NYU Cancer Institute at New York University Medical Center New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health

    Investigators

    • Principal Investigator: James N. Tsay, MD, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT00301119
    Other Study ID Numbers:
    • 8896
    • NYU-H-8896-06-B
    • NCT00212524
    First Posted:
    Mar 10, 2006
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by NYU Langone Health
    small cell lung cancer
    non-small cell lung cancer
    smoker lung cancer screening
    low dose spiral CT screening
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Mar 15, 2022