Point of Care Test to Diagnosed Colorectal Cancer and Polyps in Low Middle Income Countries
NCT ID: NCT03173729
Last Updated: 2024-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
926 participants
OBSERVATIONAL
2017-02-11
2023-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Phase 1 Cohort 1
CRC (n = 150)
No interventions assigned to this group
Phase 1 Cohort 2
Precancerous polyps (n = 150)
No interventions assigned to this group
Phase 1 Cohort 3
Normal controls (n = 150)
No interventions assigned to this group
Phase 2 Field Test
75 patients who are high risk for CRC as described in the eligibility
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.
Phase 2 Validation Study Cohort 1
Family history of CRC (n = 330)
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.
Phase 2 Validation Study Cohort 2
LGI bleeding (n = 240)
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.
Phase 2 Validation Study Cohort 3
Patients with history of CRC (n = 75)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Obafemi Awolowo University Teaching Hospital
OTHER
Responsible Party
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Olusegun Alatise
Dr
Locations
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Endoscopy Unit, University of Ilorin Teaching Hospital
Ilorin, Kwara State, Nigeria
Federal Medical Center
Owo, Ondo State, Nigeria
Endoscopy Unit, University College Hospital
Ibadan, Osun State, Nigeria
Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals
Ile-Ife, Osun State, Nigeria
Ladoke Akintola University Teaching Hospital
Osogbo, Osun State, Nigeria
Countries
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Other Identifiers
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ERC/2017/02/11
Identifier Type: -
Identifier Source: org_study_id
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