Colorectal CancerNCT07649057
A Study of a Urine Test to Detect Colorectal Cancer
An observational study of Colorectal Cancer and Precancerous Polyp, run by Memorial Sloan Kettering Cancer Center at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Precancerous Polyp, Rectal Bleeding
- What is being tested?
- 3-metabolite biosensor
- How many people
- 210 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 11 Jun 2026to 11 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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-
Show all 9Show fewer
- Patients with colonoscopy demonstrating no colon or premalignant or malignant pathology
- Age ≥ 18
- Willingness to participate in the study
Who cannot join
None listed.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Peter Kingham, MD, 212-639-5260
Ghana1 site, 1 recruiting
- Not yet recruiting
Korle Bu Teaching Hospital (Data Collection Only)
Accra
Antionette Bediako-Bowan, MD, FWACS, FGCS, PhD, abediako-bowan@ug.edu.gh
South Africa1 site, 1 recruiting
- Not yet recruiting
Wits Donald Gordon Medical Centre (Data Collection Only)
Johannesburg
Brendan Bebington, MBChB, FCS, 011 7263390/1
Tanzania1 site, 1 recruiting
- Not yet recruiting
Kilimanjaro Christian Medical Centre (Data Collection Only)
Moshi
Alex Mremi, PhD, +255 717 083 983, alex.mremi@kcmcu.ac.tz
About this study
Official title: 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.
- Conditions
- Colorectal Cancer, Precancerous Polyp, Rectal Bleeding, CRC
- Being tested
- 3-metabolite biosensor
- Keywords
- Colorectal Cancer, Precancerous Polyp, Rectal Bleeding, Symptoms of Colorectal Cancer, CRC, Memorial Sloan Kettering Cancer Center, 26-187
- Medical subject headings
- Colorectal Neoplasms, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-metabolite biosensorDiagnostic test
3-metabolite biosensor will identify participants with colorectal cancer (CRC) and precancerous polyps
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: 3-metabolite biosensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start11 Jun 2026
- Primary completion11 Jun 2028 (estimated)
- Study completion11 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Kingham, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649057
- Sponsor's protocol ID
- 26-187
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Success of a Urine Metabolite Point-of-care Colorectal Cancer Early Diagnosis Test in Africa
- ClinicalTrials.gov ID
- NCT07649057
- Acronym / sponsor ID
- 26-187
- Conditions
- Colorectal Cancer, Precancerous Polyp, Rectal Bleeding, CRC
- Keywords
- Colorectal Cancer, Precancerous Polyp, Rectal Bleeding, Symptoms of Colorectal Cancer, CRC, Memorial Sloan Kettering Cancer Center, 26-187
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 11 Jun 2028 (estimated)
- Study completion
- 11 Jun 2028 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Colorectal Cancer/CRC | – | Diagnostic Test: 3-metabolite biosensorParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Patient presents with one of the following:
- Age ≥ 18
- Willingness to participate in the study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-metabolite biosensor3-metabolite biosensor will identify participants with colorectal cancer (CRC) and precancerous polyps | Diagnostic test | Participants with Colorectal Cancer/CRC |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Kingham, MD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Precancerous Polyp, run by Memorial Sloan Kettering Cancer Center at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Ghana, South Africa, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Kingham, MD (212-639-5260, kinghamP@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of 3-metabolite biosensor (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.