Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 7:01 AM
Study NCT ID:
NCT05679960
Status:
SUSPENDED
Last Update Posted:
2024-04-05
First Post:
2022-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point of Care, Real-Time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low-and Middle-Income Countries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 645}}, 'statusModule': {'whyStopped': 'The urine POC device seems not to be promising in colorectal cancer screening', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2022-12-23', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Urine PolypDx device in detecting colorectal cancer', 'timeFrame': 'One month', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Sensitivity Urine PolypDx device in detecting colorectal cancer (CRC)', 'timeFrame': 'One month', 'description': 'Proportion of those urine PolyDx device detects to have CRC that actually have CRC'}, {'measure': 'Specificity Urine PolypDx device in detecting colorectal cancer (CRC)', 'timeFrame': 'One month', 'description': 'Proportion of those urine PolyDx device detects not to have CRC that actually do not have CRC'}, {'measure': 'Positive Predictive Value Urine PolypDx device in detecting colorectal cancer (CRC)', 'timeFrame': 'One month', 'description': 'Proportion of those who test positive with urine PolyDx device that actually do have CRC that actually have CRC'}, {'measure': 'Negative Predictive Value Urine PolypDx device in detecting colorectal cancer (CRC)', 'timeFrame': 'One month', 'description': 'Proportion of those who test negative with urine PolyDx device that actually do not have CRC that actually have CRC'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer Screening']}, 'descriptionModule': {'briefSummary': '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.\n\nObjectives:\n\nPrimary Objective:\n\nIn 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.\n\nEndpoints: the endpoint will be the calculation of the validity (sensitivity and specificity) of the tool. Positive and negative predictive values will also be calculated.\n\nStudy population:\n\nPatients \\> 40 years of age with LGI bleeding for more than one-week OR\n\n* Patients who are high risk due to a family history of CRC (first-degree relative)\n* 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)\n* 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\n\nI. The study will evaluate the validity and acceptability of the POC biosensor device in Nigeria.\n\nDescription 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.\n\nStudy duration:\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 40 years of age with LGI bleeding for more than one week OR\n* Patients who are high risk due to a family history of CRC (first-degree relative)\n* 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)\n* Patients with a diagnosis of stage I-III CRC who have no evidence of disease\n\nExclusion Criteria:\n\ncriteria\n\n* Patients who are unable to provide written informed consent;\n* Previous diagnosis, treatment, or surgery for any cancer other than CRC\n* Age younger than 40 years with no family history of CRC\n* Any significant medical comorbidities that the anesthesiologist or surgeon determines is a contraindication for colonoscopy in their facility.\n* Inability to provide a urine sample no fewer than 3 days before colonoscopy.\n* Inability to fully complete the patient satisfaction survey tool\n* Diagnosis of or suspected inflammatory bowel disease.'}, 'identificationModule': {'nctId': 'NCT05679960', 'briefTitle': 'Point of Care, Real-Time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low-and Middle-Income Countries', 'organization': {'class': 'OTHER', 'fullName': 'Obafemi Awolowo University Teaching Hospital'}, 'officialTitle': 'Point of Care, Real-Time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low-and Middle-Income Countries', 'orgStudyIdInfo': {'id': 'NHREC/01/01/2007-18/10/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients low gastrointestinal tract bleeding', 'description': 'Patients presenting in the surgical outpatients or emergency department with low gastrointestinal tract bleeding', 'interventionNames': ['Diagnostic Test: Urine PolypDx machine Versus Colonoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants who are high risk due to a family history of CRC', 'description': 'First degree relatives of patients diagnosed with colorectal cancer', 'interventionNames': ['Diagnostic Test: Urine PolypDx machine Versus Colonoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with a diagnosis of stage I-III CRC who have no evidence of disease', 'description': 'Patients previously diagnosed of stage I-III CRC and managed in the hospital but are now having no evidence of disease', 'interventionNames': ['Diagnostic Test: Urine PolypDx machine Versus Colonoscopy']}], 'interventions': [{'name': 'Urine PolypDx machine Versus Colonoscopy', 'type': 'DIAGNOSTIC_TEST', 'description': '1. Urine samples of the participants in each group will be analyzed to check for preidentified metabolites that signified colorectal cancer\n2. 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', 'armGroupLabels': ['Participants who are high risk due to a family history of CRC', 'Patients low gastrointestinal tract bleeding', 'Patients with a diagnosis of stage I-III CRC who have no evidence of disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220005', 'city': 'Ile-Ife', 'state': 'Osun State', 'country': 'Nigeria', 'facility': 'Obafemi Awolowo University Teaching Hospital', 'geoPoint': {'lat': 7.4824, 'lon': 4.56032}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The data will be available after publication of the data', 'ipdSharing': 'YES', 'description': 'All individual participant data (IPD) will be shared', 'accessCriteria': 'Data will be made accessible upon reasonable request directed to the principal investigator of this study by any researcher in related fields'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Obafemi Awolowo University Teaching Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, {'name': 'University of Alberta', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor/Consultant Surgeon', 'investigatorFullName': 'Olusegun Alatise', 'investigatorAffiliation': 'Obafemi Awolowo University Teaching Hospital'}}}}