Genetic and Environmental Risk Factors for Esophageal Cancer in Patients With Esophageal Cancer and in Healthy Participants in Northern Iran - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00544843

Purpose

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
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: study of socioeconomic and demographic variables 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	Phase I

Study Type:	Observational
Official Title:	Gastric and Esophageal Malignancies in Northern Iran (GEMINI): Phase I: Case-Control Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

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

Primary Outcome Measures:

Causes of esophageal cancer
Comparison of risk factors in patients with or without esophageal cancer

Estimated Enrollment:	1200
Study Start Date:	March 2003
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To find the causes of squamous cell carcinoma of the esophagus in Golestan Province.
To compare various risk factors for esophageal cancer in patients with the disease as well as in healthy participants.

OUTLINE: Participants are stratified by esophageal cancer status (yes [cases] vs no [controls]).

Group I (esophageal cancer cases): Patients undergo two interviews to provide information about age, ethnicity, and other demographic data; family and personal medical history; habits, such as tobacco, opium, and alcohol consumption; diet; physical activity; oral hygiene; animal contact; and signs and symptoms of upper gastrointestinal disease.

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):
- Neighborhood controls: Participants undergo interviews, environmental risk-factor assessment, and blood, hair, and toenail collection as in group I. Some consenting participants may undergo optional biopsy for tissue collection, evaluation, and storage as in group I.
- Hospital controls: Patients undergo assessments as in group I.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria for esophageal cancer cases:

Histologically confirmed squamous cell carcinoma of the esophagus
Resides in Gonbad, Minodasht, Kalaleh, Ramyan, Azad-Shahr, Maraveh-Tappeh, or the surrounding villages AND referred to the Atrak Clinic

Inclusion criteria for controls:

Symptoms of upper gastrointestinal disease AND no esophageal cancer
Meets 1 of the following criteria:
- Resides in the neighborhood of case patients
- Referred to one of four hospitals in Gonbad City (i.e., Shohada, Motahary, Khatam, and Borzouieh) or to the Taleghani Clinic

PATIENT CHARACTERISTICS:

No expected major, long-term, changes in diet or lifestyle due to major gastrointestinal diseases, chronic malignancies, or diabetes (controls)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544843

Locations

Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Sanford M. Dawsey, MD

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000564508, NCI-03-C-N146
Study First Received:	October 13, 2007
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00544843 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on February 08, 2010