A Study of a Urine Test to Detect Colorectal Cancer
Determining the Success of a Urine Metabolite Point-of-care Colorectal Cancer Early Diagnosis Test in Africa
1 other identifier
observational
210
4 countries
4
Brief Summary
The purpose of this study is to find out whether a urine test can detect colorectal cancer (CRC) and precancerous polyps in participants living in Ghana, Tanzania, and South Africa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2026
CompletedStudy Start
First participant enrolled
June 11, 2026
CompletedFirst Posted
Study publicly available on registry
June 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 11, 2028
June 15, 2026
June 1, 2026
2 years
June 11, 2026
June 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity of 3-metabolite biosensor
The study will validate a 3-metabolite biosensor that identifies participants with colorectal cancer (CRC) and precancerous polyps in Ghana, Tanzania and South Africa. The primary aim is to show that the sensitivity and specificity in other regions are as good as the Nigerian estimates (i.e. 90% and 80% respectively).
up to 1 year
Study Arms (1)
Participants with Colorectal Cancer/CRC
Participants will either have symptoms of colorectal cancer/CRC, presented for a screening colonoscopy, or one of the following: pathologic diagnosis of CRC, colonoscopy demonstrating adenomatous polyps, or colonoscopy demonstrating no colon or premalignant or malignant pathology
Interventions
3-metabolite biosensor will identify participants with colorectal cancer (CRC) and precancerous polyps
Eligibility Criteria
Data and samples will be collected from 3 sites in Africa: Korle Bu Teaching Hospital/University of Ghana Medical School in Ghana; Kilimanjaro Christian Medical Centre in Tanzania and Wits Donald Gordon Medical Centre, Wits Donald Gordon Medical Research Institute in South Africa. Consent will occur at these sites.
You may qualify if:
- Patient presents with one of the following:
- Patients with symptoms of CRC (such as rectal bleeding for a week) -OR-
- Patients who present for a screening colonoscopy -OR-
- Has received one of the following within 3 weeks of the planned urine collection
- Patients with a pathologic diagnosis of CRC either by colonoscopy or resection specimens -OR-
- Patients with colonoscopy demonstrating adenomatous polyps -OR-
- Patients with colonoscopy demonstrating no colon or premalignant or malignant pathology
- Age ≥ 18
- Willingness to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Korle Bu Teaching Hospital (Data Collection Only)
Accra, Ghana
Wits Donald Gordon Medical Centre (Data Collection Only)
Johannesburg, South Africa
Kilimanjaro Christian Medical Centre (Data Collection Only)
Moshi, Tanzania
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Kingham, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2026
First Posted
June 15, 2026
Study Start
June 11, 2026
Primary Completion (Estimated)
June 11, 2028
Study Completion (Estimated)
June 11, 2028
Last Updated
June 15, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.