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Genetic and Environmental Risk Factors Related to Esophageal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01035398
First received: December 17, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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 Intervention
Esophageal Cancer
 Genetic: DNA analysis
Genetic: polymorphism analysis
Other: questionnaire administration

Study Type: Observational
Official Title: Molecular Epidemiology of Esophageal Cancer: Pilot Project

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Polymorphisms in various pathways, DNA repair, free-radical formation, inflammatory genes, metastatic potential, and cell cycle or tumor suppression in blood samples [ Designated as safety issue: No ]
  • Comparison of presence or absence of variant polymorphisms between cases and controls [ Designated as safety issue: No ]
  • Correlation between polymorphisms in blood samples and polymorphisms in tissue specimens [ Designated as safety issue: No ]
  • Analyses of dietary factors and Helicobacter pylori infection (previous vs current) [ Designated as safety issue: No ]

Estimated Enrollment: 1000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035398

Locations
United States, Massachusetts
Harvard School of Public Health Recruiting
Boston, Massachusetts, United States, 02115
Contact: David C. Christiani, MD     617-726-9274        
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital     877-726-5130        
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
Principal Investigator: David C. Christiani, MD Massachusetts General Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01035398     History of Changes
Other Study ID Numbers: CDR0000450143, MGH-1999-P-010178/23, MGH-99-7814
Study First Received: December 17, 2009
Last Updated: December 17, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage 0 esophageal cancer
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013