Lung Cancer Clinical Trial; Biomarkers in Screening Participants For Lung Cancer

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Biomarkers in Screening Participants For Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
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


Clinical trial summary from the National Cancer Institute's PDQ® database

Publications of Results:
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]
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
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms



ClinicalTrials.gov processed this record on February 10, 2009


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