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Molecular and Genetic Analysis of Lung Cancer

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03029325
Collaborator
National Cancer Institute (NCI) (NIH)
12,000
Enrollment
1
Location
363
Duration (Months)
33.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigators use a genome-wide approach within a case-control design to identify SNPs that show evidence of association with lung cancer risk and survival.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Investigators also investigate how genetic variants may affect cancer treatment, at various stages of disease development, in order to determine prognostic and predictive factors for survival.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    12000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Molecular and Genetic Analysis of Lung Cancer
    Study Start Date :
    Jun 1, 1993
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Survival among patients at different stages of lung cancer and treatment will be measured using questionnaires along with medical chart data to monitor treatment and disease progression [20 years]

      Study lung cancer development in a case control study. We will look at three separate outcome measures specified below

    Secondary Outcome Measures

    1. Overall survival [20 years]

      Measurement from time of diagnosis to death will be obtained

    2. Progression-free survival [20 years]

      Time of diagnosis to disease progression (measured by metastasis)

    3. Treatment toxicities [20 years]

      Effects on ECOG and physical sequelae from treatment (radiation, chemotherapy and other treatment modalities will be analyzed)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • healthy controls: participants without evidence of any cancer

    • cases: pathology proven primary lung cancer

    Exclusion Criteria:
    • younger than 18 years old

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: David C Christiani, MD, Harvard TH Chan School of Public Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Christopher Christiani, Elkan Blout Professor at Harvard TH Chan School of Public Health, Professor of Medicine Harvard Medical School, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT03029325
    Other Study ID Numbers:
    • 1999P-004935
    • 5P30CA006516-50
    First Posted:
    Jan 24, 2017
    Last Update Posted:
    Apr 21, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Apr 21, 2022