Viewing Study NCT00450788



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Last Modification Date: 2024-10-26 @ 9:31 AM
Study NCT ID: NCT00450788
Status: COMPLETED
Last Update Posted: 2024-05-16
First Post: 2007-03-17

Brief Title: Esophageal Cancer in Northeastern Iran
Sponsor: National Cancer Institute NCI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: The Golestan Cohort Study of Esophageal Cancer
Status: COMPLETED
Status Verified Date: 2024-08-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: Esophageal cancer is the sixth most common cause of cancer death worldwide killing over 380000 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 10010syear 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 50000 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
07-C-N120 None None None