An observational study in Colorectal Cancer, Precancerous Polyp and Rectal Bleeding, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Memorial Sloan Kettering Cancer Center · Observational
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 210 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
Patient presents with one of the following:
Has received one of the following within 3 weeks of the planned urine collection
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
Diagnostic Test: 3-metabolite biosensor
3-metabolite biosensor will identify participants with colorectal cancer (CRC) and precancerous polyps
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).
Time frame: up to 1 year
Plan to share: Yes — 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.
Started Jun 2026 (actual). Primary completion is estimated for Jun 2028, 24 months after the start.
Of 528 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 132. This study's planned 24 months is below that.
Counting every sponsor, half of 645 studies reached it within 51 months; a quarter within 27 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
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