NCT03173729

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 926 (actual)
• Sponsor: Obafemi Awolowo University Teaching Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

In Phase 1, urine will be collected from 450 Nigerian patients (150 with CRC, 150 with polyps, and 150 patients with no colon premalignant or malignant pathology. These samples will be used to refine a handheld biosensor. This handheld biosensor is intended to be a cost-effective POC diagnostic test highly sensitive for CRC in Nigerian patients. In Phase 2, the biosensor device will be piloted in Nigeria with 75 patients that are high-risk for CRC.. After the pilot, POC test in real-time analysis on urine from 645 patients who are in one of three groups: 1.\> 40 years of age with rectal bleeding; 2.a family history of CRC; 3. have a diagnosis of CRC. All patients will receive a colonoscopy. Beliefs and barriers related to urine testing for CRC will be investigated. Study will be completed within 5 years.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Biosensor Point of Care Device	This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps.

Timeline

• Start date: 2017-02-11
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2017-06-02
• Last updated: 2024-04-04

Locations

5 sites across 1 country: Nigeria