A Pilot for a Case-Control Study of Esophageal Squamous Cell Carcinoma in Western Kenya

NCT00901173 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 372

Last updated 2020-04-24

No results posted yet for this study

Summary

Background:

* Esophageal cancer is the sixth leading cause of cancer deaths worldwide. Two primary cell types, squamous cell carcinoma and adenocarcinoma, account for most cases. Of the two, esophageal squamous cell carcinoma (ESCC) accounts for more than 80 percent of all deaths from esophageal cancer. Many cases occur in certain areas with defined geographic boundaries, including parts of Kenya.
* Studies of ESCC in developed countries (such as the United States) suggest that heavy tobacco and alcohol use, poor diet, and low socioeconomic status are the primary risk factors. Males and African Americans are also at higher risk. However, these risk factors do not fully explain the prevalence of cases in several of the identified geographic areas.
* ESCC is the most common cancer seen at Tenwek Hospital in western Kenya, and a notable number of patients are 30 years of age or younger.

Objectives:

* To test the feasibility of a new protocol by recruiting visitors to Tenwek Hospital and volunteers from the general population for study purposes.
* To use the new protocol to obtain blood and urine samples from ESCC cases in Tenwek Hospital and from nonpatient volunteers.

Eligibility:

* Hospital patients and volunteers who live within 50 kilometers of Tenwek Hospital in western Kenya.

Design:

* All participants will complete a questionnaire and provide blood and urine samples for testing.

* The questionnaire will include questions about individual and family medical history, living conditions, lifestyle, habits, and diet.
* Blood and urine samples will be collected from all participants after the questionnaire.
* Biological samples will be shipped to the United States for further testing.
* Treatment will not be offered as part of this study.

Conditions

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Christian Abnet, Ph.D. · National Cancer Institute (NCI)

Eligibility

Min Age
7 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-10
Primary Completion
2020-04-20
Completion
2020-04-20

Countries

  • Kenya

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00901173 on ClinicalTrials.gov