RecruitingNCT07649057

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

210 participants

Start Date

Jun 11, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria9

  • 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

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Interventions

DIAGNOSTIC_TEST3-metabolite biosensor

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


Locations(4)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Korle Bu Teaching Hospital (Data Collection Only)

Accra, Ghana

Wits Donald Gordon Medical Centre (Data Collection Only)

Johannesburg, South Africa

Kilimanjaro Christian Medical Centre (Data Collection Only)

Moshi, Tanzania

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NCT07649057


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