Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Biomarkers in Screening Participants For Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Biomarker/Laboratory analysis, Screening Active Over 50 NCI NYU-H-8896-06-B NCT00301119

Objectives

1. Identify and validate biomarkers for the early detection of lung cancer in individuals at low- or high-risk for smoking-related cancers.
2. Identify preneoplastic cellular changes and lesions in these patients.

Entry 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)

Prior/Concurrent Therapy:

• Not specified

Patient Characteristics:

• Not pregnant
• No prior malignancy except nonmelanoma skin cancer

Expected Enrollment

A total of 1,450 participants will be accrued for this study.

Outcomes

Lung cancer diagnosis as measured by CT scan findings and pathology findings annually

Precancerous lung nodules as measured by CT scan findings and pathology findings annually

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.

Greenberg AK, Rimal B, Felner K, et al.: S-adenosylmethionine as a biomarker for the early detection of lung cancer. Chest 132 (4): 1247-52, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NYU Cancer Institute at New York University Medical Center

William Rom, MD, MPH, Principal investigator		Ph: 212-263-6479 Email: william.rom@med.nyu.edu

U.S.A.
New York
	New York
	NYU Cancer Institute at New York University Medical Center
		William Rom, MD, MPH	Ph:  212-263-6479
			Email: william.rom@med.nyu.edu

Registry Information
Official Title		NYU Lung Cancer Biomarker Center
Trial Start Date		2000-05-08
Trial Completion Date		2010-02-28 (estimated)
Registered in ClinicalTrials.gov		NCT00301119
Date Submitted to PDQ		2005-10-04
Information Last Verified		2008-12-07
NCI Grant/Contract Number		U01-CA86137, P30-CA16087