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RecruitingObservational

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

NCT ID: NCT07649057Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-06-15

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.

Arms & interventions

  • Diagnostic Test3-metabolite biosensor

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

Outcome measures

Primary

  • 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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Recruiting
Peter Kingham, MD · Contact
212-639-5260