Esophageal Cancer in Northeastern Iran

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT00450788
Collaborator
(none)
50,045
1

Study Details

Study Description

Brief Summary

Background:

-Esophageal cancer is the most common cancer in Iran s Golestan Province. Nutritional deficiencies, ethnicity and environmental exposures might contribute to the development of this disease.

Objectives:

-To better understand the cause of esophageal cancer in Golestan Province and to reduce its occurrence there.

Eligibility:

-Adults from the Gonbad, Aq-Qala and Kalaleh districts of eastern Golestan Province in Iran.

Design:
  • The study is a collaboration between NIH, the Digestive Disease Research Center of Teheran University of Medical Sciences, and the International Agency for Research on Cancer.

  • Participants complete a lifestyle questionnaire and food frequency questionnaire.

  • Samples of participants blood, urine, hair and toenail clippings are obtained.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Esophageal cancer is the sixth most common cause of cancer death worldwide, killing over 380,000 people each year. Over 80% of esophageal cancers occur in developing countries, where the great majority of cases are squamous cell carcinomas. Esophageal cancer is characterized by striking geographic variation in incidence. One remarkable high-risk area, called the Central Asian Esophageal Cancer Belt, stretches from the Caspian Sea across Central Asia to northern China and includes focal areas with recorded incidence rates greater than 100/10s/year in both genders. For the past 20 years, D CEG investigators have studied esophageal and gastric cancer in one of these extremely high-risk areas, Linxian, China, at the eastern end of the Belt. While these studies have discovered new risk factors for esophageal cancer in this region, they have produced an incomplete explanation of the etiology of this disease. Now we have the opportunity to perform similar studies in another of these extremely high-risk areas, Golestan Province, Iran, at the other end of the high-risk Belt. The people of Golestan, in northeastern Iran, are geographically, culturally and ethnically quite different from the people of Linxian, and they appear to be similar only in their extraordinarily high rates of esophageal cancer. Performing similar studies in these two exceptional populations will give us a better chance to identify important new modifiable risk factors for esophageal cancer in both places.

    Our cohort study is a collaboration between the Digestive Disease Research Center of Tehran University of Medical Sciences (DDRC), the International Agency for Research on Cancer (IARC), and DCEG. The study has recruited 50,000 adults in three administrative districts of eastern Golestan Province. Baseline assessments included lifestyle questionnaire, a semi-quantitative food frequency questionnaire, and collection of blood, hair, nails and urine. Follow up will includes active surveillance by a study team, aided by a comprehensive health network in the rural areas, a GI referral clinic in the largest town, and a provincial cancer registry. The main hypotheses include dietary hypotheses (low consumption of fruits and vegetables, high consumption of hot tea), exposure to potential carcinogens (tobacco, PAHs from non-tobacco sources), novel exposures (opium, animal contact), and genetic susceptibility. Some cross sectional and a few total mortality analyses have been completed. Annual follow-up is ongoing.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50045 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Golestan Cohort Study of Esophageal Cancer
    Study Start Date :
    Mar 15, 2007

    Arms and Interventions

    Arm Intervention/Treatment
    Golestan Cohort

    Cohort of adults from Golestan region in Iran

    Outcome Measures

    Primary Outcome Measures

    1. cancer incidence [continuous]

      The main hypotheses include dietary hypotheses (low consumption of fruits and vegetables, high consumption of hot tea), exposure to potential carcinogens (tobacco, PAHs from non-tobacco sources), novel exposures (opium, animal contact), and genetic susceptibility.

    Secondary Outcome Measures

    1. Mortality [Continuous]

      Some cross sectional and a few total mortality analyses have been completed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • Ages 40 to 75

    • Patients with esophogeal cancer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Digestive Disease Research Institute Tehran Iran, Islamic Republic of 14117-1313

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Christian Abnet, Ph.D., National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00450788
    Other Study ID Numbers:
    • 999907120
    • 07-C-N120
    First Posted:
    Mar 22, 2007
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Jan 19, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Cancer Institute (NCI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 19, 2022