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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00544843 |
RATIONALE: Gathering information about genetic and environmental risk factors in patients with esophageal cancer and in healthy participants in Northern Iran may help doctors learn more about the disease.
PURPOSE: This phase I clinical trial is studying genetic and environmental risk factors for esophageal cancer in patients with esophageal cancer and in healthy participants in Northern Iran.
Condition | Intervention | Phase |
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Esophageal Cancer Healthy, no Evidence of Disease |
Procedure: biopsy Procedure: comparative genomic hybridization Procedure: diagnostic endoscopic procedure Procedure: evaluation of cancer risk factors Procedure: gene expression profiling Procedure: laboratory biomarker analysis Procedure: physiologic testing Procedure: polymorphism analysis Procedure: protein expression analysis Procedure: questionnaire administration Procedure: study of high risk factors Procedure: study of socioeconomic and demographic variables Procedure: surface-enhanced laser desorption/ionization-time of flight mass spectrometry |
Phase I |
Study Type: | Observational |
Official Title: | Gastric and Esophageal Malignancies in Northern Iran (GEMINI): Phase I: Case-Control Study |
Estimated Enrollment: | 1200 |
Study Start Date: | March 2003 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Participants are stratified by esophageal cancer status (yes [cases] vs no [controls]).
Patients also undergo collection of biological specimens, including tissue, blood, hair, and toenails. Tissue samples obtained from diagnostic endoscopic biopsy are evaluated for gene expression patterns using microarray analysis of genomic DNA. Blood samples are evaluated for nutritional, genetic (e.g., polymorphisms in genomic DNA), and protein markers of esophageal cancer. Blood samples are also assessed for serum protein patterns by surface-enhanced laser desorption ionization analysis. Hair and toenail samples are examined for environmental risk factors for esophageal cancer, including carcinogenic minerals and compounds such as fungal toxins. Other environmental risk factors (i.e., life-style, habits, and nutritional status) are assessed through questionnaires and objective measurements in biological specimens. Biological specimens are stored for future genetic or risk-assessment studies of esophageal cancer.
Group II (controls):
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Inclusion criteria for esophageal cancer cases:
Inclusion criteria for controls:
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
Iran, Islamic Republic of | |
Tehran University of Medical Sciences | |
Tehran, Iran, Islamic Republic of |
Principal Investigator: | Sanford M. Dawsey, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000564508, NCI-03-C-N146 |
Study First Received: | October 13, 2007 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00544843 |
Health Authority: | United States: Federal Government |
healthy, no evidence of disease squamous cell carcinoma of the esophagus stage 0 esophageal cancer stage I esophageal cancer |
stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer |
Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Squamous cell carcinoma Healthy Carcinoma Epidermoid carcinoma |
Digestive System Diseases Head and Neck Neoplasms Carcinoma, squamous cell Gastrointestinal Neoplasms Esophageal Diseases Carcinoma, Squamous Cell Esophageal neoplasm |
Neoplasms Neoplasms by Site |