A Study of a Urine Test to Detect Colorectal Cancer

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.

Recruiting

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Key information

Conditions

Colorectal Cancer CRC Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Hemorrhage Gastrointestinal Neoplasms Hemorrhage Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Polyp Rectal Bleeding Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Korle Bu Teaching Hospital (Data Collection Only), Accra, Ghana

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3-metabolite biosensor

Diagnostic Test

3-metabolite biosensor will identify participants with colorectal cancer (CRC) and precancerous polyps

Primary outcomes

Sensitivity of 3-metabolite biosensor

Time frame: up to 1 year

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).

Study contacts

Contact information is provided by the study sponsor or research team.

Alexia Iasonos, PhD

CONTACT

[email protected]

646-227-3557

Peter Kingham, MD

CONTACT

[email protected]

212-639-5260

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Determining the Success of a Urine Metabolite Point-of-care Colorectal Cancer Early Diagnosis Test in Africa

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jun 15, 2026
Registry last updated: Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed