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NCT Number: NCT01035398

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Harvard School of Public Health, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Comparison of presence or absence of variant polymorphisms between cases and controls

    Time frame: 2000-2016

  3. Correlation between polymorphisms in blood samples and polymorphisms in tissue specimens

    Time frame: 2000-2016

  4. Analyses of dietary factors and Helicobacter pylori infection (previous vs current)

    Time frame: 2000-2016

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Molecular Epidemiology of Esophageal Cancer: Pilot Project

Important dates

Study start
2000
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2009
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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