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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Point of Care, Real-time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low and Middle Income Countries

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: Biosensor Point of Care Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase 1 Cohort 1<br>CRC (n = 150) | |
| Phase 1 Cohort 2<br>Precancerous polyps (n = 150) | |
| Phase 1 Cohort 3<br>Normal controls (n = 150) | |
| Phase 2 Field Test<br>75 patients who are high risk for CRC as described in the eligibility | Diagnostic Test: Biosensor Point of Care Device<br>* This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps.<br>|
| Phase 2 Validation Study Cohort 1<br>Family history of CRC (n = 330) | Diagnostic Test: Biosensor Point of Care Device<br>* This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps.<br>|
| Phase 2 Validation Study Cohort 2<br>LGI bleeding (n = 240) | Diagnostic Test: Biosensor Point of Care Device<br>* This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps.<br>|
| Phase 2 Validation Study Cohort 3<br>Patients with history of CRC (n = 75) | Diagnostic Test: Biosensor Point of Care Device<br>* This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of a point of care device to diagnose colorectal cancer and polyps | We have designed a urine-based point of care diagnostic test to risk-stratify patients at high-risk for colorectal cancer. that will have 50% specificity and 80% sensitivity among Nigerian targeted population. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that are willing to consider continued colorectal cancer surveillance with a urine point of care test. | The barriers and attitudes of patients towards a point of care urine test will be used to predict how many patients are willing to use this methodology. | 3 years | 
| Cost per patient of point of care urine test for diagnosing patients with colorectal cancer and polyps. | The cost per patient will be determined using a cost effectiveness model already developed for the urine screening test in high-income countries. | 3 years |