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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 |
Genetic: comparative genomic hybridization Genetic: microarray analysis Genetic: polymorphism analysis Genetic: protein expression analysis Other: laboratory biomarker analysis Other: physiologic testing Other: questionnaire administration Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry Procedure: biopsy Procedure: diagnostic endoscopic procedure Procedure: evaluation of cancer risk factors Procedure: study of high risk factors Procedure: study of socioeconomic and demographic variables |
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]).
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: | February 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00544843 History of Changes |
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 Gastrointestinal Diseases Esophageal Neoplasms Esophageal Cancer Healthy Squamous Cell Carcinoma Carcinoma |
Digestive System Diseases Esophageal Disorder Head and Neck Neoplasms Epidermoid Carcinoma Gastrointestinal Neoplasms Esophageal Diseases Carcinoma, Squamous Cell |
Neoplasms Neoplasms by Site Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Head and Neck Neoplasms Esophageal Neoplasms Gastrointestinal Neoplasms Esophageal Diseases |