Urine test to help spot colorectal cancer and polyps
Official title: Determining the Success of a Urine Metabolite Point-of-care Colorectal Cancer Early Diagnosis Test in Africa
Run by Memorial Sloan Kettering Cancer Center · NCT07649057 · Data updated 2026-11-12
This study tests a urine-based 3-metabolite biosensor to see if it can detect colorectal cancer and precancerous polyps in adults in Ghana, Tanzania, and South Africa.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 4 sites (New York, New York and 3 other locations) |
| Status | Recruiting |
| Started | June 11, 2026 |
| Main results expected | June 11, 2028 |
| Study ends | June 11, 2028 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT07649057 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older who have symptoms of colorectal cancer, are undergoing screening colonoscopy, or have had recent colonoscopy results (CRC, adenomatous polyps, or benign/premalignant findings).
✕Probably not a fit
Participants without colorectal cancer or polyps, or those whose condition does not produce distinct urine biomarkers, may not benefit from the test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates whether a urine biomarker test can identify colorectal cancer and precancerous polyps. Participants include adults with symptoms such as rectal bleeding, those undergoing screening colonoscopy, and individuals who have recently had colonoscopy findings. The test uses a 3-metabolite biosensor to analyze urine samples collected across multiple sites. Data collection is conducted at Memorial Sloan Kettering and partner centers for performance comparison. The study emphasizes real-world applicability in diverse African populations.
Why it matters
Potential benefit: If successful, the urine test could provide a noninvasive method to screen for colorectal cancer and precancerous polyps, enabling earlier detection.
How similar studies have gone: Other studies have explored urine biomarkers for colorectal cancer, but this specific 3-metabolite biosensor approach in these populations is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States Recruiting -
Korle Bu Teaching Hospital (Data Collection Only)
Accra, Ghana Not yet recruiting -
Wits Donald Gordon Medical Centre (Data Collection Only)
Johannesburg, South Africa Not yet recruiting -
Kilimanjaro Christian Medical Centre (Data Collection Only)
Moshi, Tanzania Not yet recruiting
Study contacts
- Principal investigator: Peter Kingham, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Peter Kingham, MD
- Email: kinghamP@mskcc.org
- Phone: 212-639-5260
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.