Genetic and Environmental Risk Factors Related to Esophageal Cancer

Mass General Brigham

Status: Active, not recruiting

Conditions: Esophageal Cancer

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01035398

5R01CA109193-04 (U.S. NIH Grant/Contract)

MGH-1999-P-010178/23 (Other Identifier)

CDR0000450143

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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