Point of Care Test to Diagnosed Colorectal Cancer and Polyps in Low Middle Income Countries

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.

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.