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| Name | Class |
|---|---|
| Memorial Sloan Kettering Cancer Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Cohort 1 | CRC (n = 150) | ||
| Phase 1 Cohort 2 | Precancerous polyps (n = 150) | ||
| Phase 1 Cohort 3 | Normal controls (n = 150) | ||
| Phase 2 Field Test | 75 patients who are high risk for CRC as described in the eligibility |
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| Phase 2 Validation Study Cohort 1 | Family history of CRC (n = 330) |
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| Phase 2 Validation Study Cohort 2 | LGI bleeding (n = 240) |
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| Phase 2 Validation Study Cohort 3 | Patients with history of CRC (n = 75) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biosensor Point of Care Device | Diagnostic Test | This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps. |
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| 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 |
| 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. |
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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:
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Patients in Phase 1 has a pathologic diagnosis of colon cancer (either by colonoscopy or resection specimens), or colonoscopy demonstrating adenomatous polyps or no colon premalignant or malignant pathology.
Patients in Phase 2 are > 40 years of age with LGI bleeding, or at high-risk due to family history, or with a history of CRC
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopy Unit, University of Ilorin Teaching Hospital | Ilorin | Kwara State | Nigeria | |||
| Federal Medical Center |
Will follow the NIH/NCI approved guidelines
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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A urine sample is collected with 3 weeks of their surgery or colonoscopy.
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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 |
| Owo |
| Ondo State |
| Nigeria |
| Endoscopy Unit, University College Hospital | Ibadan | Osun State | Nigeria |
| Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals | Ile-Ife | Osun State | 220005 | Nigeria |
| Ladoke Akintola University Teaching Hospital | Osogbo | Osun State | Nigeria |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |