Clinical trial · Observational
Point of Care Test to Diagnosed Colorectal Cancer and Polyps in Low Middle Income Countries
Point of Care, Real-time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low and Middle Income Countries
NCT03173729CI-TRIAL-00075731completedClinicalTrials.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)
This is a-two phase study. Phase 1 will adapt a 3-metabolite biosensor that identifies patients with colorectal cancer (CRC) and precancerous polyps to Nigerian patients. Phase 2 will pilot test and evaluate the point-of-care (POC) biosensor device in Nigeria.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biosensor Point of Care Device | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- label
- Phase 1 Cohort 1
- description
- CRC (n = 150)
- label
- Phase 1 Cohort 2
- description
- Precancerous polyps (n = 150)
- label
- Phase 1 Cohort 3
- description
- Normal controls (n = 150)
- label
- Phase 2 Field Test
- description
- 75 patients who are high risk for CRC as described in the eligibility
- interventionNames
- Diagnostic Test: Biosensor Point of Care Device
- label
- Phase 2 Validation Study Cohort 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \> 40 years of age with LGI bleeding OR * Patients who are high risk due to family history of CRC o Must be at most 10 years younger than when relative presented with CRC (for example, a patient with a relative diagnosed at age 40 with CRC will be eligible after age 30) OR * Patients with a diagnosis of stage I-III CRC who have no evidence of disease Exclusion Criteria: * Patients who are unable to provide written informed consent; * Previous diagnosis, treatment, or surgery for any cancer other than CRC * Age younger than 40 years with no family history of CRC * Any significant medical comorbidities * Inability to provide a urine sample no fewer than 3 days before colonoscopy * Inability to fully complete the patient satisfaction survey tool * Diagnosis of or suspected inflammatory bowel disease.
References
Publications (0)
Data not yet available
No reference posted for this study.