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Lung Cancer Biomarkers and Screening (NYULCBC)

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ClinicalTrials.gov Identifier: NCT00301119
Recruitment Status : Recruiting
First Posted : March 10, 2006
Last Update Posted : March 15, 2022
Information provided by (Responsible Party):
NYU Langone Health

Brief 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.

Condition or disease
Lung Cancer

Detailed Description:


  • 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.

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Study Type : Observational
Estimated Enrollment : 6860 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NYU Lung Cancer Biomarker Center
Study Start Date : May 2000
Estimated Primary Completion Date : May 2030
Estimated Study Completion Date : May 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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.

Primary Outcome Measures :
  1. Lung cancer diagnosis as measured by CT scan findings and pathology findings annually [ Time Frame: 07/01/2015 ]

Secondary Outcome Measures :
  1. Precancerous lung nodules as measured by CT scan findings and pathology findings annually [ Time Frame: 07/01/2015 ]

Biospecimen Retention:   Samples With DNA
blood serum, plasma, urine, sputum, BAL, lung tissue, buccal swab

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.



  • 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)


  • Not pregnant
  • No prior malignancy except nonmelanoma skin cancer


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301119

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Contact: James N Tsay, MD, MPH 212-598-6351 Jun-Chieh.Tsay@nyulangone.org
Contact: Ellen M Eylers, RN, MSN, MPH 212-263-6126 ellen.eylers@nyumc.org

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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
NYU Langone Health
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Principal Investigator: James N. Tsay, MD NYU Langone Health
Publications of Results:
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00301119    
Obsolete Identifiers: NCT00212524
Other Study ID Numbers: 8896
First Posted: March 10, 2006    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
small cell lung cancer
non-small cell lung cancer
smoker lung cancer screening
low dose spiral CT screening
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases