Recruiting

Urine Test

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07649057

Conditions

Colorectal Cancer

Precancerous Polyp

Rectal Bleeding

CRC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3-metabolite biosensor

Study Details

Brief 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.

Conditions

Colorectal Cancer

Precancerous Polyp

Rectal Bleeding

CRC

Study ID

NCT07649057

Start date

Jun 11, 2026

Status verified date

Jun, 2026

Completion date

Jun 11, 2028

Anticipated

Primary completion date

Jun 11, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

210 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

3-metabolite biosensor

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

Primary outcome measure

  • Sensitivity of 3-metabolite biosensor [ Time Frame: up to 1 year ]

Central Contacts and Locations

Central contacts

Peter Kingham, MD

212-639-5260kinghamP@mskcc.org

Alexia Iasonos, PhD

646-227-3557iasonosa@mskcc.org

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Peter Kingham, MD

212-639-5260

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Colorectal Cancer
  • Precancerous Polyp
  • Rectal Bleeding
  • Symptoms of Colorectal Cancer
  • CRC
  • Memorial Sloan Kettering Cancer Center
  • 26-187

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-06-15.