Genetic and Environmental Risk Factors Related to Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT01035398|
Recruitment Status : Recruiting
First Posted : December 18, 2009
Last Update Posted : September 5, 2017
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|
- 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 Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Molecular Epidemiology of Esophageal Cancer: Pilot Project|
|Study Start Date :||April 2000|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||September 2022|
- 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 ]
- Comparison of presence or absence of variant polymorphisms between cases and controls [ Time Frame: 2000-2016 ]
- Correlation between polymorphisms in blood samples and polymorphisms in tissue specimens [ Time Frame: 2000-2016 ]
- Analyses of dietary factors and Helicobacter pylori infection (previous vs current) [ Time Frame: 2000-2016 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035398
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130|
|Harvard School of Public Health||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: David C. Christiani, MD 617-726-9274|
|Principal Investigator:||David C. Christiani, MD||Massachusetts General Hospital|