Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-01-17 @ 12:57 AM
Study NCT ID:
NCT06432192
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2024-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D024801', 'term': 'Tauopathies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1474}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2024-05-22', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'APOE Genotype', 'timeFrame': 'Baseline', 'description': "Blood samples will be collected to establish the feasibility of detecting several gene mutations associated with the risk of Alzheimer's disease/ Cardiovascular disorder and validation of analytical parameters"}], 'secondaryOutcomes': [{'measure': 'Specimen stability', 'timeFrame': 'Baseline, 24hrs, 5 days, 28 days, 3 months, 12 months, 24 months', 'description': 'Blood samples will be collected to establish the stability of PAXgene DNA samples at different timepoints after storage at -20° and -80°C.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polygenic risk', 'APOE, Apolipoprotein', 'Neurodegenerative disorders', 'Dementia', 'Alzheimer disease', 'Genetic risks'], 'conditions': ['Genetic Health Risks']}, 'descriptionModule': {'briefSummary': 'Firalis SA and its affiliate Amoneta Diagnostics SAS are developing novel in-vitro-diagnostic (IVD) tests for diverse diagnostic applications for major human diseases, including cardiovascular, and neurodegenerative disorders. These tests detect several gene mutations related to the above-mentioned pathologies. The development of IVD tools requires the evaluation of analytical parameters including biomarker stability.\n\nThe present specific study therefore aims to collect whole blood samples in PAXgene DNA tubes to complete the analytical validation of IVD tools and the evaluation of the stability of the DNA in PAXgene DNA tubes and the reagents in the IVD tools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy donors', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Donors who sign the informed consent forms for sample collection and for genotyping.\n* Adults, both genders, aged 18-85 years.\n* Not under any administrative or legal supervision\n\nExclusion Criteria:\n\n* Anyone who did not sign the Informed Consent form.\n* Subjects aged below 18 years and older than 85 years are excluded.\n* Pregnant, parturient and nursing women are excluded'}, 'identificationModule': {'nctId': 'NCT06432192', 'acronym': 'ApoDiag', 'briefTitle': 'A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Firalis SA'}, 'officialTitle': 'ApoDiag: A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis', 'orgStudyIdInfo': {'id': '2023-A02120-45'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'APOE E', 'description': 'The cohort will be genotyped to determine the phenotype of the APOE allele', 'interventionNames': ['Diagnostic Test: APO-Easy']}], 'interventions': [{'name': 'APO-Easy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Testing for the APOE genotype using the APO-Easy Genotyping test', 'armGroupLabels': ['APOE E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54100', 'city': 'Nancy', 'country': 'France', 'facility': 'EFS GEST', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'EFS GEST', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Huseyin Firat, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Firalis SA'}, {'name': 'Lucas Pham-Van, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Firalis SA'}, {'name': 'Joanna Michel', 'role': 'STUDY_CHAIR', 'affiliation': 'Firalis SA'}, {'name': 'Sthepanie Boutillier, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Firalis SA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Firalis SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}