Point of Care, Real-Time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low-and Middle-Income Countries
Study Details
Study Description
Brief Summary
Study description: the study is a clinical trial aimed at assessing the validity of a point-of-care tool developed for colorectal cancer screening using urine metabolites.
Objectives:
Primary Objective:
In the pilot phase, investigators will field test the POC device in Nigeria on 75 patients who are high-risk for CRC and then validate the urine metabolite signature using a large cohort of 645 patients at high risk for CRC and polyps. This will allow us to determine the sensitivity and specificity of this device and these signatures for CRC and polyps.
Endpoints: the endpoint will be the calculation of the validity (sensitivity and specificity) of the tool. Positive and negative predictive values will also be calculated.
Study population:
Patients > 40 years of age with LGI bleeding for more than one-week OR
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Patients who are high risk due to a family history of CRC (first-degree relative)
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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)
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Patients with a diagnosis of stage I-III CRC who have no evidence of disease Both males and females will be involved in the study
- The study will evaluate the validity and acceptability of the POC biosensor device in Nigeria.
Description of sites/facilities enrolling participants: the study will be conducted at Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC) which hosts the head office of African Research Group for Oncology (ARGO). The study will also run concurrently at other ARGO collaborating sites. All the ARGO collaborating sites are tertiary health care facilities with experienced personnel to oversee the study. The pilot study will, however, take place in OAUTHC alone.
Study duration:
The accrual time for the validation study is 2.5 years. Participant Duration: the study will require initial one-time contact. Those that are positive during the screening with the POC biosensor device will be booked for colonoscopy. Hence, for participants with positive results to complete the study may require 2 weeks on average.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Patients low gastrointestinal tract bleeding Patients presenting in the surgical outpatients or emergency department with low gastrointestinal tract bleeding |
Diagnostic Test: Urine PolypDx machine Versus Colonoscopy
Urine samples of the participants in each group will be analyzed to check for preidentified metabolites that signified colorectal cancer
Colonoscopy, which is the gold standard for colorectal cancer diagnosis/screening will be performed on all the participants positive for metabolites signifying CRC on Urine PolypDx machine in all the groups
|
| Active Comparator: Participants who are high risk due to a family history of CRC First degree relatives of patients diagnosed with colorectal cancer |
Diagnostic Test: Urine PolypDx machine Versus Colonoscopy
Urine samples of the participants in each group will be analyzed to check for preidentified metabolites that signified colorectal cancer
Colonoscopy, which is the gold standard for colorectal cancer diagnosis/screening will be performed on all the participants positive for metabolites signifying CRC on Urine PolypDx machine in all the groups
|
| Active Comparator: Patients with a diagnosis of stage I-III CRC who have no evidence of disease Patients previously diagnosed of stage I-III CRC and managed in the hospital but are now having no evidence of disease |
Diagnostic Test: Urine PolypDx machine Versus Colonoscopy
Urine samples of the participants in each group will be analyzed to check for preidentified metabolites that signified colorectal cancer
Colonoscopy, which is the gold standard for colorectal cancer diagnosis/screening will be performed on all the participants positive for metabolites signifying CRC on Urine PolypDx machine in all the groups
|
Outcome Measures
Primary Outcome Measures
- Accuracy of Urine PolypDx device in detecting colorectal cancer [One month]
Results from the urine assay will be compared with the histology report of the tissue taken during colonoscopy, the gold standard for colorectal cancer diagnosis. Sensitivity, specificity, positive predictive value, and negative predictive values will be calculated
Secondary Outcome Measures
- Sensitivity Urine PolypDx device in detecting colorectal cancer (CRC) [One month]
Proportion of those urine PolyDx device detects to have CRC that actually have CRC
- Specificity Urine PolypDx device in detecting colorectal cancer (CRC) [One month]
Proportion of those urine PolyDx device detects not to have CRC that actually do not have CRC
- Positive Predictive Value Urine PolypDx device in detecting colorectal cancer (CRC) [One month]
Proportion of those who test positive with urine PolyDx device that actually do have CRC that actually have CRC
- Negative Predictive Value Urine PolypDx device in detecting colorectal cancer (CRC) [One month]
Proportion of those who test negative with urine PolyDx device that actually do not have CRC that actually have CRC
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients > 40 years of age with LGI bleeding for more than one week OR
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Patients who are high risk due to a family history of CRC (first-degree relative)
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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)
-
Patients with a diagnosis of stage I-III CRC who have no evidence of disease
Exclusion Criteria:
criteria
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Patients who are unable to provide written informed consent;
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Previous diagnosis, treatment, or surgery for any cancer other than CRC
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Age younger than 40 years with no family history of CRC
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Any significant medical comorbidities that the anesthesiologist or surgeon determines is a contraindication for colonoscopy in their facility.
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Inability to provide a urine sample no fewer than 3 days before colonoscopy.
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Inability to fully complete the patient satisfaction survey tool
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Diagnosis of or suspected inflammatory bowel disease.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Obafemi Awolowo University Teaching Hospital | Ife | Osun | Nigeria | 220005 |
Sponsors and Collaborators
- Obafemi Awolowo University Teaching Hospital
- Memorial Sloan Kettering Cancer Center
- University of Alberta
- National Institutes of Health (NIH)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NHREC/01/01/2007-18/10/2021