Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT02104518
Status:
COMPLETED
Last Update Posted:
2014-10-28
First Post:
2014-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Different G6PD Testing Platforms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005955', 'term': 'Glucosephosphate Dehydrogenase Deficiency'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Left-over venous blood will be spun down and buffy coat and extracted DNA will be stored in labeled tubes for later G6PD genotyping and characterization.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-27', 'studyFirstSubmitDate': '2014-04-01', 'studyFirstSubmitQcDate': '2014-04-03', 'lastUpdatePostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine concordance between point-of-care tests and spectrophotometric gold standard', 'timeFrame': 'Six months', 'description': 'Percent agreement between the quantitative results of the G6PD tests and the spectrophotometric test.'}], 'secondaryOutcomes': [{'measure': 'Determine sensitivity and specificity of the point-of-care G6PD tests against the spectrophotometric gold standard', 'timeFrame': 'Six months', 'description': 'This is to determine the variance of the sensitivity and specificity of different G6PD point-of-care tests compared to the gold standard.'}, {'measure': 'Measure categorical accuracy of point-of-care G6PD test against by the spectrophotometric gold standard', 'timeFrame': 'Six months', 'description': 'Percent agreement between the qualitative G6PD test and the categorical results of the spectrophotometric gold standard'}, {'measure': 'Determine concordance between point-of-care G6PD tests and the florescent spot test', 'timeFrame': 'Six months', 'description': 'Compare sensitivity \\& specificity of qualitative results of the G6PD test and the categorical results of the florescent spot test.'}, {'measure': 'Define the G6PD-normal and deficient profiles in the SW Sumba population.', 'timeFrame': 'Six months', 'description': 'Determine the profile of the SW Sumba area in regards to normal and deficient population spread.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['glucose-6-phosphate dehydrogenase', 'point-of-care diagnostic testing'], 'conditions': ['Glucose-6-Phosphate Dehydrogenase Deficiency']}, 'descriptionModule': {'briefSummary': 'In this study the investigators propose to evaluate the performance of several G6PD testing platforms.', 'detailedDescription': 'In this study we propose to evaluate the performance of several G6PD testing platforms. We will also determine the concordance between point-of-care G6PD tests and the spectrophotometric gold standard. This study will also access the sensitivity and specificity between the point-of-care G6PD tests. This study will take place in Indonesia, specifically in the SW Sumba region. We will enroll 700 volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will enroll up to 700 volunteers from the SW Sumba region in Indonesia. The SW Sumba region is inland, and isolated from other nearby villages. The general population of SW Sumba are substance farmers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be at least five years of age\n* Patient / parental consent\n* Patient willing to allow donated sample to be used in future research\n\nExclusion Criteria:\n\n* Patients with severe malaria or other severe illness\n* Patients who received a blood transfusion in the last three months\n* Patients unwilling to allow donated blood to be used in future research'}, 'identificationModule': {'nctId': 'NCT02104518', 'briefTitle': 'Evaluation of Different G6PD Testing Platforms', 'organization': {'class': 'OTHER', 'fullName': 'PATH'}, 'officialTitle': 'Evaluation of a Point-of-care G6PD Diagnostic Test', 'orgStudyIdInfo': {'id': 'Eijkman-69'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'G6PD testing', 'description': 'Blood samples will be tested for G6PD activity levels'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Eijkman Institute for Molecular Biology', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Ari Winasti Satyagraha, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Eijkman Institute for Molecular Biology'}, {'name': 'Kevin Baird, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Oxford University Clinical Research Unit Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PATH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eijkman Institute for Molecular Biology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}