Clinical trial · Observational
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
NCT07649057CI-TRIAL-00114809recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| CRC | Colorectal Carcinoma | ALIAS | 0.90 |
| Precancerous Polyp | Precancerous Polyp | ONTOLOGY_EXACT | 0.98 |
| Rectal Bleeding | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-metabolite biosensor | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with Colorectal Cancer/CRC
- description
- 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
- interventionNames
- Diagnostic Test: 3-metabolite biosensor
Primary outcomes (1)
- measure
- Sensitivity of 3-metabolite biosensor
- timeFrame
- up to 1 year
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 studyReferences
Publications (0)
Data not yet available
No reference posted for this study.