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Lung Cancer Biomarkers and Screening (NYULCBC)

This study is currently recruiting participants.
Verified October 2017 by New York University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT00301119
First Posted: March 10, 2006
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
New York University School of Medicine
  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:


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 ]

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 6860
Study Start Date: May 2000
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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.

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
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


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

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
First Submitted: March 8, 2006
First Posted: March 10, 2006
Last Update Posted: October 13, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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