Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Esophageal squamous cell carcinoma
- timeFrame
- At diagnosis
- description
- determined by pathology results from endoscopic biopsy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
- Maximum age
- 99 Years
Show eligibility criteria text
* Cases: INCLUSION CRITERIA: 1. Consent to participate in the study 2. Pathologically diagnosed with esophageal squamous cell carcinoma at Tenwek Hospital, Bomet Kenya 3. Primary residence within 50 kilometers of Tenwek Hospital, Bomet Kenya EXCLUSION CRITERIA: 1. Does not consent to participation in the study 2. Mental impairment that precludes consenting to or completing the study questionnaire Controls: INCLUSION CRITERIA: 1. Consent to participation in the study 2. No previous history of malignancy 3. Primary residence within 50 kilometers of Tenwek Hospital, Bomet Kenya EXCLUSION CRITERIA: 1. Does not consent to participation in the study 2. Mental impairment that precludes consenting to or completing the study questionnaire
References
Publications (3)
- BACKGROUNDDawsey 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 21124934
- BACKGROUNDWhite 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 12241722
- BACKGROUNDNieminen 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 23155139