Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-03 @ 10:46 AM
Study NCT ID:
NCT05292768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-03-23
First Post:
2022-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Are Mast Cells Involved in Autoinflammatory Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056587', 'term': 'Cryopyrin-Associated Periodic Syndromes'}, {'id': 'D000090267', 'term': 'Mast Cell Activation Syndrome'}], 'ancestors': [{'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000094482', 'term': 'Chronic Inducible Urticaria'}, {'id': 'D000080223', 'term': 'Chronic Urticaria'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D000096703', 'term': 'Cold Urticaria'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000090362', 'term': 'Mast Cell Activation Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood and urine samples Digestive, renal or cutaneous biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 590}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2022-03-14', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': ': presence of MCAS', 'timeFrame': 'at inclusion', 'description': 'presence of clinical and biological markers of MCAS'}], 'secondaryOutcomes': [{'measure': 'comparison of clinical symptoms of MC activation between groups', 'timeFrame': 'at inclusion', 'description': 'we will compare clinical symptoms of MC activation between AID patients and other groups'}, {'measure': 'MC mediators associated to AID', 'timeFrame': 'at inclusion', 'description': 'determine which MC mediators are elevated in AID and if they correlate with inflammation'}, {'measure': 'MC infiltration in biopsies from AID patients', 'timeFrame': 'at inclusion, retrospectively', 'description': 'we will study MC infiltration in digestive, renale and cutaneous biopsies from patients with AID and compare them with biopsies from the other groups from subgroups of patients who had a biopsy performed.'}, {'measure': 'basophilic polynuclear activation in AID patients', 'timeFrame': 'at inclusion, retrospectively', 'description': 'we will study basophilic polynuclear activation from blood samples of AID patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autoinflammatory disease', 'Mast cells', 'Mast cell activation syndrome'], 'conditions': ['Autoinflammatory Disease', 'FMF', 'TRAPS', 'MKD', 'Cryopyrin Associated Periodic Syndrome', 'Haploinsufficiency']}, 'descriptionModule': {'briefSummary': 'Autoinflammatory diseases (AID) are caused by innate immunity dysregulation. AID pathophysiology is only partly understood, especially in the case of unclassified AID. Mast cells (MC) are innate immune cells associated with a spectrum of disease between systemic mastocytosis and mast cell activation syndrome. The implication of MC has been shown in cryopyrin associated periodic syndrome (CAPS).Our aim is to evaluate the involvement of MC in AID by assessing clinical and biological signs of MC activation and studying cutaneous and digestive biopsies.', 'detailedDescription': 'Autoinflammatory diseases (AID) are caused by innate immunity dysregulation and characterized by recurrent bouts of fever, frequently associated with digestive, articular or cutaneous symptoms, and sometimes ocular, auricular or neurologic inflammation. The most frequent monogenic AID is Familial Mediterranean fever (FMF).\n\nDespite recent genetic progress AID pathophysiology is only partly understood, especially in the case of unclassified AID.\n\nMast cells (MC) are innate immune cells associated with a spectrum of disease between systemic mastocytosis and mast cell activation syndrome (MCAS). In MCAS, patients have various symptoms including abdominal pain, bloating, pruritus, flush, anxiety, fatigue, among which some are similar to those seen in patients with AID. The implication of MC has been shown in cryopyrin associated periodic syndrome (CAPS).\n\nOur hypothesis is that MC could be involved in AID pathophysiology,\n\nIn order to test this hypothesis, we plan to study :\n\n* clinical MC activation symptoms via a standardized clinical score\n* biological MC mediators : by measuring total serum tryptase and histamine in total blood, plasma and urine\n* MC infiltration on gastro-intestinal (GI) tract and cutaneous biopsies We will compare clinical MC activation score in AID patients to patients with mastocytosis, with other inflammatory diseases, and with healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatients and outpatients wil be recruited in tertiary university centres of the Assitance Publique des Hopitaux de Paris.\n\nHealthy controls will be recruited from volunteer healthcare workers in Assitance Publique des Hopitaux de Paris', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients \\>18 years old with Auto-inflammatory diseases already followed up at the CeRéMAIA (french national reference center for autoinflamamtory diseases and AA amyloidosis) of Tenon hospital and included in the JIRcohorte\n* Healthy adult controls, age- and sex-matched with MAI patients, and controls with mastocytosis, an immuno-inflammatory disease.\n* Subject affiliated to or entitled to a social security scheme\n* Collection of the patient's or healthy control's non-opposition\n\nExclusion Criteria:\n\n* Subjects unable to answer questions or express themselves\n* Subjects who do not speak French\n* Subject deprived of liberty or under legal protection."}, 'identificationModule': {'nctId': 'NCT05292768', 'acronym': 'INFLAMAST', 'briefTitle': 'Are Mast Cells Involved in Autoinflammatory Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Are Mast Cells Involved in Autoinflammatory Diseases', 'orgStudyIdInfo': {'id': 'APHP210126'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with AID'}, {'label': 'Control patients with mastocytosis'}, {'label': 'Control patients with normal digestive biopsy'}, {'label': 'Control patients with renal biopsy'}, {'label': 'Control patients with inflammatory disease'}, {'label': 'Healthy control from healthcare workers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Service de Médecine Interne', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Sophie GEORGIN-LAVIALLE, PU-PH', 'role': 'CONTACT', 'email': 'sophie.georgin-lavialle@aphp.fr', 'phone': '+33 (0)1 56 01 72 04 or 60 77'}, {'name': 'Nabiha Sbeih, MD', 'role': 'CONTACT', 'email': 'nabiha.sbeih@gmail.com', 'phone': '+33 (0)1 84 82 74 03'}], 'overallOfficials': [{'name': 'Sophie GEORGIN-LAVIALLE, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut Imagine', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}