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Lung Cancer Biomarkers and Screening (NYULCBC)

This study is currently recruiting participants.
Verified May 2013 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00301119
First received: March 8, 2006
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  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
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NYU Lung Cancer Biomarker Center

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Lung cancer diagnosis as measured by CT scan findings and pathology findings annually [ Time Frame: 07/01/2015 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Precancerous lung nodules as measured by CT scan findings and pathology findings annually [ Time Frame: 07/01/2015 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood serum, plasma, urine, sputum, BAL, lung tissue, buccal swab


Estimated Enrollment: 6860
Study Start Date: May 2000
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
lung cancer screening cohort
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
observational only. no intervention. patients with CT findings suspicious for lung cancer who are undergoing bronchoscopy and/or surgery.

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 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
Sampling Method:   Non-Probability Sample
Study Population

healthy subjects at risk for lung cancer and controls from community, private physician referrals, local trade unions, employee health fairs, word of mouth and print advertisements.

patient referrals from physician outpatient offices and inpatients with CT findings suspicious for lung cancer.

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

Contacts
Contact: William N Rom, MD, MPH 212-263-6479 william.rom@nyumc.org
Contact: Ellen M Eylers, RN, MSN, MPH 212-263-6126 ellen.eylers@nyumc.org

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
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:

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00301119     History of Changes
Obsolete Identifiers: NCT00212524
Other Study ID Numbers: CDR0000456198, NYU-H-8896-06-B
Study First Received: March 8, 2006
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
small cell lung cancer
non-small cell lung cancer
smoker lung cancer screening
low dose spiral CT screening

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013