Lung Cancer Biomarkers and Screening (NYULCBC)

NYU Langone Health

Status: Enrolling

Conditions: Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00301119

8896

NYU-H-8896-06-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,850 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

10,850 participants in 2 patient groups

lung cancer screening cohort

Description:

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

Description:

observational only. no intervention. patients with CT findings suspicious for lung cancer who are undergoing bronchoscopy and/or surgery.