Clinical trial NCT01035398: Genetic and Environmental Risk Factors Related to Esophageal Cancer
Official title: Molecular Epidemiology of Esophageal Cancer: Pilot Project
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Esophageal Cancer
Keywords: stage 0 esophageal cancer
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-12-18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

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.

Eligibility 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

Primary outcomes:
measure: Polymorphisms in various pathways, DNA repair, free-radical formation, inflammatory genes, metastatic potential, and cell cycle or tumor suppression in blood samples
timeFrame: 2000-2016
measure: Comparison of presence or absence of variant polymorphisms between cases and controls
timeFrame: 2000-2016
measure: Correlation between polymorphisms in blood samples and polymorphisms in tissue specimens
timeFrame: 2000-2016
measure: Analyses of dietary factors and Helicobacter pylori infection (previous vs current)
timeFrame: 2000-2016
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Harvard School of Public Health
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: David C. Christiani, MD
role: PRINCIPAL_INVESTIGATOR
References: