NCT00339742

Stomach and Esophageal Cancers in Northern Iran

Completed Last updated 11 December 2020

What this trial tests

trial in Esophageal Cancer in 1,163 participants. Completed in 13 February 2020.

Timeline

25 March 2003

Primary endpoint
26 March 2010

13 February 2020

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,163
Start date	25 March 2003
Primary completion	26 March 2010
Estimated completion	13 February 2020
Sites	1 location across Iran

Conditions studied

• Esophageal Cancer — all drugs for Esophageal Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 99, any sex, with Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study, sponsored jointly by the National Cancer Institute and the Tehran University of Medical Sciences, will explore the causes of cancers of the stomach and esophagus (the tube that runs between the mouth and the stomach) in Northern Iran. This is a unique area of study for the following reasons:

* Some of the highest rates of esophageal cancer in the world have been reported in northeastern Iran 109 cases per 100,000 men and 175 cases per 100,000 women each year about 40 times higher than the rates of this cancer in the United States.
* In this area of Iran, unlike most areas of the world, the disease affects more women than men.
* Within 300 miles along the southern border of the Caspian Sea, the rates fall to 10 cases per 100,000 people per year.

The high rates of disease in this area, the unique geographic distribution of cases, and the exceptionally high rate in women make Northern Iran a promising site for studying esophageal and stomach cancers.

Patients 30 years of age and older who are referred to the upper gastrointestinal disease Atrak Clinic in Gonbad, Golestan Province, Iran, with suspected esophageal cancer may be eligible for this study. In addition, control subjects 30 years of age and older with certain specified diseases will be recruited from patients referred to four hospitals in Gonbad and to the Taleghani Clinic. After giving informed consent, all participants will undergo the following procedures:

* Interviews, including questions about age, ethnicity, education, and other demographic data; habits, such as tobacco, opium, and alcohol consumption; personal and family medical history; diet, with special attention to food preservation, cooking methods, and drinking water; physical activity; occupational and residential history; body measurements; signs and symptoms of upper gastrointestinal disease; oral hygiene; animal contact; transfusion history; and family socioeconomic status.
* Blood draw (15 milliliters, or 1 tablespoon) for genetic and chemical testing for markers that may predict who gets the disease.
* Hair and nail sampling to identify minerals or compounds whose exposure may be related to esophageal cancer.
* Endoscopy to evaluate the health of the esophagus and stomach. This test will be performed on all case patients and on control participants who give their permission. Before the examination, the subject will swallow a liquid that numbs the throat and may be given a medicine through a vein to promote drowsiness. The subject will then swallow a tube (endoscope) through which the doctor can look at the esophagus and stomach and take samples of tissue to look for disease. The tissue samples will be examined microscopically and will then be stored for possible future genetic or other testing related to diagnosing or determining the risk of esophageal cancer.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Risk of gastric cancer by water source: evidence from the Golestan case-control study.
   Eichelberger L, Murphy G, Etemadi A, Abnet CC, et al · · 2015 · cited 17× · PMID 26023788 · DOI 10.1371/journal.pone.0128491
2. <i>TP53</i> Targeted Deep Sequencing of Cell-Free DNA in Esophageal Squamous Cell Carcinoma Using Low-Quality Serum: Concordance with Tumor Mutation.
   Nasrollahzadeh D, Roshandel G, Delhomme TM, Avogbe PH, et al · · 2021 · cited 7× · PMID 34073316 · DOI 10.3390/ijms22115627