NCT00450788

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,045

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 22, 2007

Completed
Last Updated

June 8, 2026

Status Verified

July 11, 2025

First QC Date

March 17, 2007

Last Update Submit

June 5, 2026

Conditions

GI DiseaseEsophageal Cancer

Keywords

EtiologyCarcinogensEsophageal CancerNatural History

Outcome Measures

Primary Outcomes (1)

  • cancer incidence

    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.

    continuous

Secondary Outcomes (1)

  • Mortality

    Continuous

Study Arms (1)

Golestan Cohort

Cohort of adults from Golestan region in Iran

Eligibility Criteria

Age30 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

* Ages 40 to 75 * Patients with esophogeal cancer

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Digestive Disease Research Institute

Tehran, 14117-1313, Iran

Location

Related Publications (3)

  • Pourshams A, Khademi H, Malekshah AF, Islami F, Nouraei M, Sadjadi AR, Jafari E, Rakhshani N, Salahi R, Semnani S, Kamangar F, Abnet CC, Ponder B, Day N, Dawsey SM, Boffetta P, Malekzadeh R. Cohort Profile: The Golestan Cohort Study--a prospective study of oesophageal cancer in northern Iran. Int J Epidemiol. 2010 Feb;39(1):52-9. doi: 10.1093/ije/dyp161. Epub 2009 Mar 30. No abstract available.

    PMID: 19332502BACKGROUND

  • Malekshah AF, Kimiagar M, Saadatian-Elahi M, Pourshams A, Nouraie M, Goglani G, Hoshiarrad A, Sadatsafavi M, Golestan B, Yoonesi A, Rakhshani N, Fahimi S, Nasrollahzadeh D, Salahi R, Ghafarpour A, Semnani S, Steghens JP, Abnet CC, Kamangar F, Dawsey SM, Brennan P, Boffetta P, Malekzadeh R. Validity and reliability of a new food frequency questionnaire compared to 24 h recalls and biochemical measurements: pilot phase of Golestan cohort study of esophageal cancer. Eur J Clin Nutr. 2006 Aug;60(8):971-7. doi: 10.1038/sj.ejcn.1602407. Epub 2006 Feb 8.

    PMID: 16465196BACKGROUND

  • Pourshams A, Saadatian-Elahi M, Nouraie M, Malekshah AF, Rakhshani N, Salahi R, Yoonessi A, Semnani S, Islami F, Sotoudeh M, Fahimi S, Sadjadi AR, Nasrollahzadeh D, Aghcheli K, Kamangar F, Abnet CC, Saidi F, Sewram V, Strickland PT, Dawsey SM, Brennan P, Boffetta P, Malekzadeh R. Golestan cohort study of oesophageal cancer: feasibility and first results. Br J Cancer. 2005 Jan 17;92(1):176-81. doi: 10.1038/sj.bjc.6602249.

    PMID: 15597107BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Christian C Abnet, Ph.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2007

First Posted

March 22, 2007

Study Start

March 15, 2007

Last Updated

June 8, 2026

Record last verified: 2025-07-11

Locations

IR(1)