NCT00901173

Completed

A Pilot for a Case-Control Study of Esophageal Squamous Cell...

National Cancer Institute (NCI)Source

NCT00901173|Completed

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

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

National Cancer Institute (NCI)ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

999909141

Secondary identifiers

09-C-N141

Study Type

observational

Actual enrollment (reported)

372

Locations

1 country

Sites

1

Timeline

Study Start

February 10, 2014

Actual (reported)

Primary Completion

April 20, 2020

Actual (reported)

Study Completion

April 20, 2020

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 372 participants
Study completion date: April 20, 2020
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 12, 2009
Actual (reported)
First Posted
May 13, 2009
Actual (reported)
Study Start
February 10, 2014
Actual (reported)
Primary Completion
April 20, 2020
Actual (reported)
Study Completion
April 20, 2020
Actual (reported)

Last Updated: April 24, 2020
Status Verified: April 2020
Last Update Submitted: April 21, 2020

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Case-Control StudyEsophageal Squamous Cell CarcinomaRisk Factors

Outcome Measures

Primary Outcomes (1)

Esophageal squamous cell carcinoma
determined by pathology results from endoscopic biopsy
At diagnosis

Eligibility Criteria

Age7 Years - 99 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

ESCC patients and controls that live within 50 km of Tenwek Hospital

You may qualify if:

Consent to participate in the study

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHlead

Study Sites (1)

Tenwek Hospital

Bornet, Kenya

Related Publications (3)

Dawsey SP, Tonui S, Parker RK, Fitzwater JW, Dawsey SM, White RE, Abnet CC. Esophageal cancer in young people: a case series of 109 cases and review of the literature. PLoS One. 2010 Nov 22;5(11):e14080. doi: 10.1371/journal.pone.0014080.
PMID: 21124934BACKGROUND
White RE, Abnet CC, Mungatana CK, Dawsey SM. Oesophageal cancer: a common malignancy in young people of Bomet District, Kenya. Lancet. 2002 Aug 10;360(9331):462-3. doi: 10.1016/S0140-6736(02)09639-3.
PMID: 12241722BACKGROUND

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

Christian Abnet, Ph.D.
National Cancer Institute (NCI)
PRINCIPAL INVESTIGATOR

Enrollment

372 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 13, 2009

Study Start

February 10, 2014

Actual (reported)

Pathologically diagnosed with esophageal squamous cell carcinoma at Tenwek Hospital, Bomet Kenya

Primary residence within 50 kilometers of Tenwek Hospital, Bomet Kenya

You may not qualify if:

Does not consent to participation in the study
Mental impairment that precludes consenting to or completing the study questionnaire
Controls:
Consent to participation in the study
No previous history of malignancy
Primary residence within 50 kilometers of Tenwek Hospital, Bomet Kenya
Does not consent to participation in the study
Mental impairment that precludes consenting to or completing the study questionnaire

Contact the study team to confirm eligibility.

Nieminen MT, Novak-Frazer L, Collins R, Dawsey SP, Dawsey SM, Abnet CC, White RE, Freedman ND, Mwachiro M, Bowyer P, Salaspuro M, Rautemaa R. Alcohol and acetaldehyde in African fermented milk mursik--a possible etiologic factor for high incidence of esophageal cancer in western Kenya. Cancer Epidemiol Biomarkers Prev. 2013 Jan;22(1):69-75. doi: 10.1158/1055-9965.EPI-12-0908. Epub 2012 Nov 15.

PMID: 23155139BACKGROUND

Primary Completion

April 20, 2020

Actual (reported)

Study Completion

April 20, 2020

Actual (reported)

Last Updated

April 24, 2020

Record last verified: 2020-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00901173
Data provider: ClinicalTrials.gov
Source updated: 2020-04-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:59 UTC

Locations

KE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations