Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-01-09 @ 2:56 PM
Study NCT ID:
NCT03473795
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-15
First Post:
2018-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing Non-Communicable Disease Registries in Africa : A Step Towards Providing Quality Data for Improving Patient Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073296', 'term': 'Noncommunicable Diseases'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples can include tissue, blood, urine, saliva, hair and nail clipping.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7566}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2018-03-16', 'studyFirstSubmitQcDate': '2018-03-16', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '# of patients that develope non-communicable diseases in Africa', 'timeFrame': '5 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient Outcomes', '18-114'], 'conditions': ['Non-Communicable Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This umbrella protocol seeks to develop robust data registries for non-communicable diseases (NCDs) in sub-Saharan Africa (SSA) with the aim of providing accurate and comprehensive data for the evaluation of such diseases in sub-Saharan African countries.Healthy volunteers will be included in the study for comparison.\n\nAdditionally, the investigators aim to describe the gut microbiome community diversity of a cohort of community dwelling Nigerians and compare with CRC patients in Nigerian and at MSK. We will collect stool for microbiome and metabolomic analysis from community dwelling persons in the catchment area of ARGO facilities in Nigeria while contemporaneously administering an extensive medical and environmental exposure questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be accrued in medical clinics in Africa as determined by the local investigators and local research staff.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 and older.\n* Suspected or confirmed diagnosis of a non-communicable disease. OR\n* Healthy volunteers/no confirmed diagnosis for comparison.\n\nExclusion Criteria:\n\n* Participants unwilling to sign consent.\n* Participants under the age of 18'}, 'identificationModule': {'nctId': 'NCT03473795', 'briefTitle': 'Developing Non-Communicable Disease Registries in Africa : A Step Towards Providing Quality Data for Improving Patient Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Developing Non-Communicable Disease Registries in Africa: A Step Towards Providing Quality Data for Improving Patient Outcomes', 'orgStudyIdInfo': {'id': '18-114'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy participants and participants diagnosed with NCDs', 'description': 'This protocol will entail prospective collection of data on healthy participants and participants diagnosed with NCDs managed at collaborating institutions in SSA. Information to be obtained includes socio-demographic data, risk factors, disease-specific data, investigation and treatment details, as well as findings during follow-up. Particular reference will be made to outcome measures such as local and distant recurrence, survival and mortality. Follow-up data will be updated during clinic visits and also via phone calls.', 'interventionNames': ['Behavioral: Questionnaire forms', 'Other: Bio-specimen samples']}], 'interventions': [{'name': 'Questionnaire forms', 'type': 'BEHAVIORAL', 'description': 'The questionnaires will include information such as socio-demographic data, risk factors, disease specific data, investigation and treatment details as well as findings during followup. Particular reference will be made to outcome measures such as local and distant recurrence, survival and mortality.', 'armGroupLabels': ['healthy participants and participants diagnosed with NCDs']}, {'name': 'Bio-specimen samples', 'type': 'OTHER', 'description': 'Samples can include tissue, blood, urine, saliva, hair and nail clipping.', 'armGroupLabels': ['healthy participants and participants diagnosed with NCDs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '900103', 'city': 'Abuja', 'state': 'Central Business District', 'country': 'Nigeria', 'facility': 'National Hospital of Abuja (Data collection only)', 'geoPoint': {'lat': 9.05785, 'lon': 7.49508}}, {'city': 'Idi Araba', 'state': 'Lagos', 'country': 'Nigeria', 'facility': 'Lagos State University Teaching Hospital', 'geoPoint': {'lat': 6.52028, 'lon': 3.35382}}, {'city': 'Sagamu', 'state': 'Ogun State', 'country': 'Nigeria', 'facility': 'Olabisis Onabanjo University Teaching Hospital', 'geoPoint': {'lat': 6.8485, 'lon': 3.64633}}, {'city': 'Owo', 'state': 'Ondo State', 'country': 'Nigeria', 'facility': 'Federal Medical Centre Owo', 'geoPoint': {'lat': 7.1962, 'lon': 5.58681}}, {'city': 'Ibadan', 'state': 'Oyo State', 'country': 'Nigeria', 'facility': 'University College Hospital', 'geoPoint': {'lat': 7.37756, 'lon': 3.90591}}, {'city': 'Ogbomoso', 'state': 'Oyo State', 'country': 'Nigeria', 'facility': 'Ladoke Akintola University of Technology', 'geoPoint': {'lat': 8.13373, 'lon': 4.24014}}, {'city': 'Enugu', 'country': 'Nigeria', 'facility': 'University Of Nigeria Teaching Hospital (UNTH) Ituku-Ozalla Enugu', 'geoPoint': {'lat': 6.44132, 'lon': 7.49883}}, {'city': 'Ikeja', 'country': 'Nigeria', 'facility': 'Lagos State University Teaching Hospital', 'geoPoint': {'lat': 6.59651, 'lon': 3.34205}}, {'city': 'Ile-Ife', 'country': 'Nigeria', 'facility': 'Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)', 'geoPoint': {'lat': 7.4824, 'lon': 4.56032}}, {'city': 'Ilorin', 'country': 'Nigeria', 'facility': 'University of Ilorin Teaching Hospitals', 'geoPoint': {'lat': 8.49664, 'lon': 4.54214}}, {'zip': '600104', 'city': 'Maiduguri', 'country': 'Nigeria', 'facility': 'University of Maiduguri Teaching Hospital (Data collection only)', 'geoPoint': {'lat': 11.84692, 'lon': 13.15712}}, {'city': 'Ondo', 'country': 'Nigeria', 'facility': 'Ondo State Trauma and Surgical Centre', 'geoPoint': {'lat': 7.09316, 'lon': 4.83528}}, {'city': 'Owo', 'country': 'Nigeria', 'facility': 'Federal Medical Centre Owo', 'geoPoint': {'lat': 7.1962, 'lon': 5.58681}}], 'overallOfficials': [{'name': 'T. Peter Kingham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}