Genetic and Environmental Risk Factors Related to Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Molecular Epidemiology of Esophageal Cancer: Pilot Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01035398
• Other study ID #: CDR0000450143
• Secondary ID: MGH-1999-P-01017
• Status: Active, not recruiting
• Start date: April 2000
• Est. completion date: September 2023

Study information

• Verified date: April 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: September 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Locations

Country	Name	City	State
United States	Harvard School of Public Health	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polymorphisms in various pathways, DNA repair, free-radical formation, inflammatory genes, metastatic potential, and cell cycle or tumor suppression in blood samples		2000-2016
Primary	Comparison of presence or absence of variant polymorphisms between cases and controls		2000-2016
Primary	Correlation between polymorphisms in blood samples and polymorphisms in tissue specimens		2000-2016
Primary	Analyses of dietary factors and Helicobacter pylori infection (previous vs current)		2000-2016