Genetic and Environmental Risk Factors Related to Esophageal Cancer
- Conditions
- Esophageal Cancer
- Registration Number
- NCT01035398
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1200
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Polymorphisms in various pathways, DNA repair, free-radical formation, inflammatory genes, metastatic potential, and cell cycle or tumor suppression in blood samples 2000-2016 Comparison of presence or absence of variant polymorphisms between cases and controls 2000-2016 Correlation between polymorphisms in blood samples and polymorphisms in tissue specimens 2000-2016 Analyses of dietary factors and Helicobacter pylori infection (previous vs current) 2000-2016
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Harvard School of Public Health
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital🇺🇸Boston, Massachusetts, United States