Colorectal Cancer Clinical Trial
Official title:
Point of Care, Real-time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low and Middle Income Countries
Verified date | April 2024 |
Source | Obafemi Awolowo University Teaching Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 926 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Nigeria | Endoscopy Unit, University College Hospital | Ibadan | Osun State |
Nigeria | Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals | Ile Ife | Osun |
Nigeria | Endoscopy Unit, University of Ilorin Teaching Hospital | Ilorin | Kwara State |
Nigeria | Ladoke Akintola University Teaching Hospital | Osogbo | Osun State |
Nigeria | Federal Medical Center | Owo | Ondo State |
Lead Sponsor | Collaborator |
---|---|
Obafemi Awolowo University Teaching Hospital | Memorial Sloan Kettering Cancer Center |
Nigeria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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