Genetic and Environmental Risk Factors Related to Esophageal Cancer

Molecular Epidemiology of Esophageal Cancer: Pilot Project

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01035398

Enrollment

Unknown

Registered

2009-12-18

Start date

2000-04-30

Completion date

2026-09-30

Last updated

2024-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

stage 0 esophageal cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer

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.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Analyses of dietary factors and Helicobacter pylori infection (previous vs current)	2000-2016
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

Countries

United States

Outcome results