Lung Cancer Biomarkers and Screening

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, Diagnostic, ScreeningActiveOver 50OtherCDR0000456198
NYU-H-8896-06-B, NCT00301119

Trial Description

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.

Further Study Information

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.

Eligibility 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 Contact Information

Trial Lead Organizations/Sponsors

NYU Cancer Institute at New York University Medical Center

    William N. Rom, Principal Investigator
    William N Rom, MD, MPH
    Ph: 212-263-6479
    Email: william.rom@nyumc.org

    Trial Sites

    U.S.A.

    New York
    New York

    NYU Cancer Institute at New York University Medical Center

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

    See All Trial Sites

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT00301119
    ClinicalTrials.gov processed this data on January 22, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.