Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 1:22 PM
Study NCT ID:
NCT06928233
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-15
First Post:
2025-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of TNFAIP3 With Immune-mediated TTP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536901', 'term': 'Thrombotic thrombocytopenic purpura, acquired'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Allele frequency of TNFAIP3 variants in cases vs controls', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'TNFAIP3 (A20) mRNA expression levels in peripheral blood', 'timeFrame': 'Baseline', 'description': 'TNFAIP3 (A20) mRNA expression levels in peripheral blood of cases versus controls'}, {'measure': 'Association between TNFAIP3 genotype and gene expression', 'timeFrame': 'Baseline'}, {'measure': 'Clinical relapse rate of iTTP during follow-up', 'timeFrame': 'Baseline', 'description': 'Association between TNFAIP3/A20 variation and iTTP relapse in iTTP patients'}, {'measure': 'Severity of acute iTTP episodes', 'timeFrame': 'Baseline', 'description': 'Association between TNFAIP3/A20 variation and the severity of acute iTTP (composite endpoint including death, treatment refractoriness, exacerbation, and prolonged disease course)'}, {'measure': 'Age at iTTP onset', 'timeFrame': 'Baseline', 'description': 'Association between TNFAIP3/A20 variation and age at onset in iTTP patients'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['A20', 'iTTP', 'TNFAIP3'], 'conditions': ['Thrombotic Thrombocytopenic Purpura, Acquired']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate whether genetic variation in the TNFAIP3 locus is associated with immune-mediated thrombotic thrombocytopenic purpura (iTTP), and whether such association is mediated by decreased expression of A20 (TNFAIP3). The study includes a case-control design to assess genotype-expression association and a cohort study to evaluate clinical outcomes such as disease relapse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patients:\n\nInclusion Criteria:\n\n* Diagnosis of iTTP\n* Above 12 years of age\n* Caucasian, Italian origin\n* Written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Patients who do not meet the above-listed criteria will be excluded from participation in the study.\n\nControls will be healthy Italian volunteers of Caucasian ethnicity, with no history of thrombotic thrombocytopenic purpura, frequency-matched to cases by age and sex, and who have provided written informed consent to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06928233', 'acronym': 'A20iTTP', 'briefTitle': 'Association of TNFAIP3 With Immune-mediated TTP', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Association of the TNFAIP3 Genomic Locus With Immune-mediated TTP', 'orgStudyIdInfo': {'id': 'A20iTTP'}, 'secondaryIdInfos': [{'id': '2022-0469', 'type': 'OTHER_GRANT', 'domain': 'Fondazione Cariplo'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with iTTP', 'description': 'Intervention: blood sampling during standard collection for routine testing, with additional sample for experimental analyses.', 'interventionNames': ['Procedure: blood sampling']}, {'type': 'OTHER', 'label': 'Healthy donors', 'description': 'Intervention: blood sampling during standard donation, with an additional sample collected for experimental analyses.', 'interventionNames': ['Procedure: blood sampling']}], 'interventions': [{'name': 'blood sampling', 'type': 'PROCEDURE', 'description': 'Blood sampling for experimental analyses.', 'armGroupLabels': ['Healthy donors', 'Patients with iTTP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Ilaria Mancini, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Ilaria Mancini', 'investigatorAffiliation': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}}}}