Biomarkers in Screening Participants For Lung Cancer - Full Text View

Sponsors and Collaborators:	New York University School of Medicine National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00301119

Purpose

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	Intervention
Lung Cancer	Other: laboratory biomarker analysis Other: screening questionnaire administration Procedure: biopsy Procedure: bronchoscopy

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening
Official Title:	NYU Lung Cancer Biomarker Center

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Lung cancer diagnosis as measured by CT scan findings and pathology findings annually [ Designated as safety issue: No ]

Secondary Outcome Measures:

Precancerous lung nodules as measured by CT scan findings and pathology findings annually [ Designated as safety issue: No ]

Estimated Enrollment:	1450
Study Start Date:	May 2000
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

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 1,450 participants will be accrued for this study.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301119

Locations

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 william.rom@med.nyu.edu

Sponsors and Collaborators

New York University School of Medicine

National Cancer Institute (NCI)

Investigators

Principal Investigator:

William N. Rom, MD, MPH

New York University School of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Greenberg AK, Rimal B, Felner K, Zafar S, Hung J, Eylers E, Phalan B, Zhang M, Goldberg JD, Crawford B, Rom WN, Naidich D, Merali S. S-adenosylmethionine as a biomarker for the early detection of lung cancer. Chest. 2007 Oct;132(4):1247-52.

Study ID Numbers:	CDR0000456198, NYU-H-8896-06-B
Study First Received:	March 8, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00301119 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

small cell lung cancer
non-small cell lung cancer
non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Small Cell
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on May 07, 2009