Stomach and Esophageal Cancers in Northern Iran

NCT00339742 | Completed

• 2 other identifiers: 99990314603-C-N146
• Study Type: observational
• Target: 1,163
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer; Case-Control Study; Environmental Risk Factors; Genetic Risk Factors

Outcome Measures

Primary Outcomes (1)

• Esophageal Cancer

  Patients who have histologically confirmed esophageal squamous cellcarcinoma of the esophagus and consent to join the study will be enrolled as cases.

  At diagnosis

Study Arms (3)

Clinic Referral controls

Controls referred by the endoscopy clinic

Esophageal Cancer cases

Histologically confirmed squamous cell cancer of the esophagus

Neighborhood controls

Controls recruited from the neighborhood

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have histologically confirmed esophageal squamous cell carcinoma of the esophagus and consent to join the study were enrolled as cases. There were 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 served as the primary control group.

You may qualify if:

• Cases:
• 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:
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Digestive Disease Research Center, Tehran University of Medical Sciences

Tehran, 14117, Iran

Location

Related Publications (3)

• Abnet CC, Kamangar F, Islami F, Nasrollahzadeh D, Brennan P, Aghcheli K, Merat S, Pourshams A, Marjani HA, Ebadati A, Sotoudeh M, Boffetta P, Malekzadeh R, Dawsey SM. Tooth loss and lack of regular oral hygiene are associated with higher risk of esophageal squamous cell carcinoma. Cancer Epidemiol Biomarkers Prev. 2008 Nov;17(11):3062-8. doi: 10.1158/1055-9965.EPI-08-0558.

  PMID: 18990747 BACKGROUND

• Islami F, Pourshams A, Nasrollahzadeh D, Kamangar F, Fahimi S, Shakeri R, Abedi-Ardekani B, Merat S, Vahedi H, Semnani S, Abnet CC, Brennan P, Moller H, Saidi F, Dawsey SM, Malekzadeh R, Boffetta P. Tea drinking habits and oesophageal cancer in a high risk area in northern Iran: population based case-control study. BMJ. 2009 Mar 26;338:b929. doi: 10.1136/bmj.b929.

  PMID: 19325180 BACKGROUND

• Islami F, Kamangar F, Nasrollahzadeh D, Aghcheli K, Sotoudeh M, Abedi-Ardekani B, Merat S, Nasseri-Moghaddam S, Semnani S, Sepehr A, Wakefield J, Moller H, Abnet CC, Dawsey SM, Boffetta P, Malekzadeh R. Socio-economic status and oesophageal cancer: results from a population-based case-control study in a high-risk area. Int J Epidemiol. 2009 Aug;38(4):978-88. doi: 10.1093/ije/dyp195. Epub 2009 May 4.

  PMID: 19416955 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, hair, nails

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Christian Abnet, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: March 25, 2003
• Primary Completion: March 26, 2010
• Study Completion: February 13, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

IR (1)