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

30 Years
Not Enrolling
Esophageal Cancer

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Trial Information

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

This case-control study (the first phase of the GEMINI project) is primarily focused on
exploring the etiology (etiologies) of squamous cell carcinoma of the esophagus in northern

Esophageal and gastric cancers, together, are responsible for more than 1,000,000 annual
deaths in the world. In 1996, cancers of the stomach and esophagus ranked first and second
respectively, among the most frequent cancers in Iran, excluding skin cancers. Some of the
highest incidence rates for esophageal cancer in the world have been reported in
Northeastern Iran, in Northern Gonbad, with Age Standardized Rates (ASR) of 109/100,000 in
men and 175/100,000 in women (1). These rates are approximately 40 times higher than those
seen in the US. In this area, unlike most areas of the world, the incidence is higher in
women than in men. Additionally, within 300 miles along the southern border of Caspian Sea,
the rates fall to 10/100,000. The highest rates of EC in the world, a unique geographical
distribution of cases, and an exceptionally high rate among women all make Northern Iran a
very intriguing site for studying this disease.

An upper-GI referral clinic (Atrak Clinic) has already been established in Gonbad, Golestan
Province, and DDRC researchers have conducted feasibility studies in this clinic. For the
case-control study, local internists and other health system workers will refer suspected
cases of esophageal cancer to the Clinic. All such patients will undergo endoscopy and
biopsy for ascertainment of diagnosis. Patients who have histologically confirmed
esophageal squamous cell carcinoma of the esophagus and consent to join the study will be
enrolled as cases. There will be two control groups in this study, one selected from the
neighborhood of case subjects and one from the patients referred to Atrak Clinic who do not
have cancer. The neighborhood control group will serve as the primary control group. Both
the cases and the controls will be interviewed and undergo collection of biological
specimens including blood, hair and nails. Free (and optional) endoscopy will also be
offered to the neighborhood controls. A four-year accrual of 300 cases, 600 neighborhood
controls and 300 clinic controls is expected.

Environmental risk factors (including life-style, habits, and nutritional status) will be
assessed through questionnaires and objective measurements in biological specimens. The
role of genetic polymorphisms will be studies using genomic DNA from cases and controls. A
subset of samples collected from cases and controls will be used to evaluate gene expression
patterns, using microarray analysis, differences in serum protein patterns, using SELDI

Inclusion Criteria



Cases will be recruited and studied in Atrak Clinic, in Gonbad City.

All patients referred to Atrak Clinic suspected to have EC.

Patients 30 years of age or above from Gonbad, Minodasht, Kalaleh, Ramyan, Azad-Shahr,
Maraveh-Tappeh, and the surrounding villages who have a histopathological diagnosis
confirming ESCC and who consent to join the study will be enrolled as cases.


Controls will be recruited into one of the four hospitals of the city (Shohada, Motahary,
Khatam, and Borzouieh), and in major referral outpatient clinic (Taleghani Clinic).

Controls will be selected from the patient 30 years of age or above who are referred to
the four hospitals of the city and Taleghani Clinic.

Only patients referred for certain diseases will be selected as controls.



No association with tobacco or alcohol consumption, which are the main known risk factors
for esophageal cancer (such as lung cancer, cardiovascular disease.

Not causing major changes in diet or life-style for a long time (such as major GI
diseases, chronic malignancies, diabetes).

Type of Study:


Study Design:


Principal Investigator

Christian Abnet, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Esophageal Cancer
  • Case-Control Study
  • Experimental Risk Factors
  • Genetic Risk Factors
  • Genetic Polymorphisms
  • Esophageal Diseases
  • Esophageal Neoplasms