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A Study of a Urine Test to Detect Colorectal Cancer

NCT07649057 · Memorial Sloan Kettering Cancer Center
In plain English

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Official title
Determining the Success of a Urine Metabolite Point-of-care Colorectal Cancer Early Diagnosis Test in Africa
About this study
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.
Eligibility criteria
Inclusion Criteria: * 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
Study design
Enrollment target: 210 participants
Age groups: adult, older_adult
Timeline
Starts: 2026-06-11
Estimated completion: 2028-06-11
Last updated: 2026-06-15
Interventions
Diagnostic Test: 3-metabolite biosensor
Primary outcomes
  • Sensitivity of 3-metabolite biosensor (up to 1 year)
Sponsor
Memorial Sloan Kettering Cancer Center · other
Contacts & investigators
ContactPeter Kingham, MD · contact · kinghamP@mskcc.org · 212-639-5260
ContactAlexia Iasonos, PhD · contact · iasonosa@mskcc.org · 646-227-3557
InvestigatorPeter Kingham, MD · principal_investigator, Memorial Sloan Kettering Cancer Center
All locations (4)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
New York, New York, United States
Korle Bu Teaching Hospital (Data Collection Only)Not Yet Recruiting
Accra, Ghana
Wits Donald Gordon Medical Centre (Data Collection Only)Not Yet Recruiting
Johannesburg, South Africa
Kilimanjaro Christian Medical Centre (Data Collection Only)Not Yet Recruiting
Moshi, Tanzania
A Study of a Urine Test to Detect Colorectal Cancer · TrialPath