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NCT00901173
A Pilot for a Case-Control Study of Esophageal Squamous Cell Carcinoma in Western Kenya
trial in Esophageal Squamous Cell Carcinoma in 372 participants. Completed in 20 April 2020.
20 April 2020
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 372 |
| Start date | 10 February 2014 |
| Primary completion | 20 April 2020 |
| Estimated completion | 20 April 2020 |
| Sites | 1 location across Kenya |
Conditions studied
- Esophageal Squamous Cell Carcinoma — all drugs for Esophageal Squamous Cell Carcinoma →
Sponsor
National Cancer Institute (NCI)
Who can join
Adults 7 to 99, any sex, with Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00901173
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00901173 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
- Last refreshed: 24 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00901173.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing