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Validation of a Multi-gene Test for Lung Cancer Risk

Sponsor
University of Toledo Health Science Campus (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01130285
Collaborator
National Cancer Institute (NCI) (NIH)
403
Enrollment
13
Locations
136
Duration (Months)
31
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the validity of a multi-gene Lung Cancer Risk Test (LCRT). In the process, the investigators will establish a bank of NBEC samples and corresponding blood samples from individuals demographically at increased risk for lung cancer.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Lung Cancer Risk Test

Detailed Description

Because more than 160,000 individuals die of lung cancer/year in the United States alone, it is important to use the best possible methods to determine whether increased surveillance of individuals at highest risk for lung cancer will result in reduced lung cancer mortality. The Lung Cancer Risk Test (LCRT) proposed for evaluation promises to accurately identify the 10-15% of the population that is most susceptible to lung cancer based on genetic predisposition. More than 90 million individuals in the United States alone are demographically at high risk for lung cancer and potential candidates for increased surveillance.

Study Design

Study Type:
Observational
Actual Enrollment :
403 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Validation of a Multi-gene Test for Lung Cancer Risk
Study Start Date :
May 1, 2011
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Non-Lung Cancer, Heavy Smoker

Subjects will be ≥ 50 years of age and have a ≥ 20 pack year smoking history and will be either healthy volunteers or individuals undergoing diagnostic bronchoscopy, with absence of lung cancer documented at the time of enrollment.

Genetic: Lung Cancer Risk Test
Measurement of gene expression in normal bronchial epithelial cells obtained at time of bronchoscopy.
Other Names:
  • LCRT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Accuracy of LCRT to predict incidental lung cancer [from time of enrollment]

      Time of diagnosis of incidental lung cancer will be compared to value of the investigational device, the Lung Cancer Risk Test (LCRT).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 20 or more pack year smoking history

    • clinical need for diagnostic bronchoscopy or consent to study driven bronchoscopy

    Exclusion Criteria:
    • Lung Cancer within 3 months after the date of enrollment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Jewish Health Denver Colorado United States 80206
    2 University of Michigan Ann Arbor Michigan United States 48109
    3 Henry Ford Detroit Michigan United States 48202
    4 Mayo Clinic Rochester Minnesota United States 55905
    5 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    6 Ohio State University Columbus Ohio United States 43221
    7 The Toledo Hospital Toledo Ohio United States 43606
    8 Mercy St. Vincent Medical Center Toledo Ohio United States 43608
    9 University of Toledo, Health Science Campus Toledo Ohio United States 43614
    10 Medical University of South Carolina Charleston South Carolina United States 29425
    11 Tennessee Valley Veterans Admin. Nashville Tennessee United States 37232
    12 Vanderbilt Nashville Tennessee United States 37232
    13 Inova Fairfax Hospital Falls Church Virginia United States 22042

    Sponsors and Collaborators

    • University of Toledo Health Science Campus
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: James Willey, MD, University of Toledo Health Science Campus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Toledo Health Science Campus
    ClinicalTrials.gov Identifier:
    NCT01130285
    Other Study ID Numbers:
    • UTHSC - 11
    • 1RC2CA148572-01
    First Posted:
    May 25, 2010
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Oct 1, 2020
    Keywords provided by University of Toledo Health Science Campus
    Lung Cancer
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Oct 19, 2020