Genetic and Environmental Risk Factors Related to Esophageal Cancer
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||Molecular Epidemiology of Esophageal Cancer: Pilot Project|
- Polymorphisms in various pathways, DNA repair, free-radical formation, inflammatory genes, metastatic potential, and cell cycle or tumor suppression in blood samples [ Time Frame: 2000-2016 ] [ Designated as safety issue: No ]
- Comparison of presence or absence of variant polymorphisms between cases and controls [ Time Frame: 2000-2016 ] [ Designated as safety issue: No ]
- Correlation between polymorphisms in blood samples and polymorphisms in tissue specimens [ Time Frame: 2000-2016 ] [ Designated as safety issue: No ]
- Analyses of dietary factors and Helicobacter pylori infection (previous vs current) [ Time Frame: 2000-2016 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood and/or buccal cells may be collected
|Study Start Date:||April 2000|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035398
|United States, Massachusetts|
|Harvard School of Public Health||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: David C. Christiani, MD 617-726-9274|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130|
|Principal Investigator:||David C. Christiani, MD||Massachusetts General Hospital|