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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Rectal Bleeding; CRC; Precancerous Polyp
• Intervention / Treatment: Diagnostic test: 3-metabolite biosensor

• Study Type: Observational
• Enrollment (Estimated): 210

Contacts and Locations

• Study Contact: Name: Peter Kingham, MD; Phone Number: 212-639-5260; Email: kinghamP@mskcc.org
• Study Contact Backup: Name: Alexia Iasonos, PhD; Phone Number: 646-227-3557; Email: iasonosa@mskcc.org

Study Locations

• Ghana
  • Accra, Ghana
    • Not yet recruiting
    • Korle Bu Teaching Hospital (Data Collection Only)
    • Contact: Antionette Bediako-Bowan, MD, FWACS, FGCS, PhD; Email: abediako-bowan@ug.edu.gh
• South Africa
  • Johannesburg, South Africa
    • Not yet recruiting
    • Wits Donald Gordon Medical Centre (Data Collection Only)
    • Contact: Brendan Bebington, MBChB, FCS; Phone Number: 011 7263390/1
• Tanzania
  • Moshi, Tanzania
    • Not yet recruiting
    • Kilimanjaro Christian Medical Centre (Data Collection Only)
    • Contact: Alex Mremi, PhD; Phone Number: +255 717 083 983; Email: alex.mremi@kcmcu.ac.tz
• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Peter Kingham, MD; Phone Number: 212-639-5260

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: 3-metabolite biosensor; 3-metabolite biosensor will identify participants with colorectal cancer (CRC) and precancerous polyps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Peter Kingham, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2026
• Primary Completion (Estimated): June 11, 2028
• Study Completion (Estimated): June 11, 2028

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Memorial Sloan Kettering Cancer Center; CRC; Rectal Bleeding; Precancerous Polyp; Symptoms of Colorectal Cancer; 26-187
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Hemorrhage; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Gastrointestinal Hemorrhage
• Other Study ID Numbers: 26-187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No