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Genetic and Environmental Risk Factors Related to Esophageal Cancer

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01035398
Collaborator
National Cancer Institute (NCI) (NIH)
1,200
Enrollment
2
Locations
281
Duration (Months)
600
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Gathering information about genes, cigarette smoking, and diet may help doctors learn more about risk factors that may cause esophageal cancer.

PURPOSE: This clinical trial is studying genetic and environmental risk factors related to esophageal cancer.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    OBJECTIVES:

    • Examine the role of several genetically-determined factors in combination with cigarette smoking and diet in the etiology and prevention of esophageal cancer.

    • Identify polymorphisms in metabolizing enzymes (e.g., phase I or II metabolism [GSTM1, GSTT1,CYP1A1, CYP3A5, mEH, NQO1, GSTP1], DNA repair [XRCC1, ERCC2], free-radical formation [MPO, MnSOD], inflammatory genes [ IL1-beta], metastatic potential [MMP1], and cell cycle or tumor suppression [p21, p53]) and related path genes of susceptibility for esophageal cancer.

    OUTLINE: Blood and tumor tissue samples are collected. DNA purified from these samples is analyzed using DNA-based assays to determine polymorphisms in various related gene pathways.

    Patients complete questionnaires concerning environmental, smoking and diet habits.

    PROJECTED ACCRUAL: A total of 1,000 tissue samples from patients and healthy participants (750 patients and 250 healthy participants) will be accrued for this study.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Molecular Epidemiology of Esophageal Cancer: Pilot Project
    Study Start Date :
    Apr 1, 2000
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Polymorphisms in various pathways, DNA repair, free-radical formation, inflammatory genes, metastatic potential, and cell cycle or tumor suppression in blood samples [2000-2016]

    2. Comparison of presence or absence of variant polymorphisms between cases and controls [2000-2016]

    3. Correlation between polymorphisms in blood samples and polymorphisms in tissue specimens [2000-2016]

    4. Analyses of dietary factors and Helicobacter pylori infection (previous vs current) [2000-2016]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    DISEASE CHARACTERISTICS:

    • Meets 1 of the following criteria:

    • Diagnosis of esophageal cancer (patient)

    • Newly diagnosed disease

    • Receiving care at Massachusetts General Hospital, Thoracic Oncology Center

    • Friend or spouse of patient (healthy participants)

    PATIENT CHARACTERISTICS:
    • No concurrent psychiatric incapacity or dementia
    PRIOR CONCURRENT THERAPY:
    • Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114
    2 Harvard School of Public Health Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: David C. Christiani, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Christopher Christiani, Pulmonary Associate, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT01035398
    Other Study ID Numbers:
    • CDR0000450143
    • MGH-1999-P-010178/23
    • 5R01CA109193-04
    First Posted:
    Dec 18, 2009
    Last Update Posted:
    Apr 15, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by David Christopher Christiani, Pulmonary Associate, Massachusetts General Hospital
    stage 0 esophageal cancer
    stage I esophageal cancer
    stage II esophageal cancer
    stage III esophageal cancer
    stage IV esophageal cancer
    Additional relevant MeSH terms:
    Esophageal Neoplasms

    Study Results

    No Results Posted as of Apr 15, 2022