Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-28 @ 7:00 PM
Study NCT ID:
NCT06186856
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2023-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological Data on Mast Cell Pathologies in France
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008415', 'term': 'Mastocytosis'}, {'id': 'D000090362', 'term': 'Mast Cell Activation Disorders'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2038-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2023-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2038-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epidemiology of mast cell disorders in France assessed by statistics on the prevalence on the various types of mast cell disorders', 'timeFrame': 'Data 2010 - 2038'}, {'measure': 'Epidemiology of mast cell disorders in France assessed by statistics on the incidence on the various types of mast cell disorders', 'timeFrame': 'Data 2010 - 2038'}], 'secondaryOutcomes': [{'measure': 'Patient characteristics', 'timeFrame': 'Data 2010 - 2038', 'description': 'age, gender, personal and family medical history'}, {'measure': 'Characteristics of mast cell disease assessed by type of disease', 'timeFrame': 'Data 2010 - 2038'}, {'measure': 'Characteristics of mast cell disease assessed by diagnostic criteria', 'timeFrame': 'Data 2010 - 2038'}, {'measure': 'Characteristics of mast cell disease assessed by symptoms of disease', 'timeFrame': 'Data 2010 - 2038'}, {'measure': 'Evolution of mast cell disease assessed by progression of skin lesions', 'timeFrame': 'Data 2010 - 2038'}, {'measure': 'Evolution of mast cell disease assessed by progression to aggressive form', 'timeFrame': 'Data 2010 - 2038'}, {'measure': 'Evolution of mast cell disease assessed by associated hemopathy', 'timeFrame': 'Data 2010 - 2038'}, {'measure': 'Evolution of mast cell disease assessed by appearance of new symptoms', 'timeFrame': 'Data 2010 - 2038'}, {'measure': 'Patient follow-up assessed by occurrence of other medical events in the patient', 'timeFrame': 'Data 2010 - 2038'}, {'measure': 'Patient follow-up assessed by overall survival', 'timeFrame': 'Data 2010 - 2038'}, {'measure': 'Types of treatment used on mastocytosis and any associated hemopathy', 'timeFrame': 'Data 2010 - 2038'}, {'measure': 'Tolerance of treatment used on mastocytosis and any associated hemopathy', 'timeFrame': 'Data 2010 - 2038'}, {'measure': 'Efficacy of treatment used on mastocytosis and any associated hemopathy', 'timeFrame': 'Data 2010 - 2038'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mast Cell Disease', 'Mastocytosis', 'mast cell-associated diseases'], 'conditions': ['Mast Cell Disorder']}, 'descriptionModule': {'briefSummary': 'Mast cell disorders constitute a heterogeneous group of diseases, including :\n\n* mastocytosis, i.e. cutaneous, indolent and severe forms of the disease, such as aggressive mastocytosis and mast cell leukemia) ;\n* mast cell-associated diseases such as mast cell activation syndrome (idiopathic, secondary or clonal), affecting both children and adults.\n\nNo epidemiological data are currently available in France.\n\nIn France, medical care of mast cell disorders is mainly provided by a rare disease network (CEREMAST), whose CRMR is located at the Necker Enfants Malades hospital in Paris. A total of 20 centers are located throughout France.\n\nOur aim is to use this network to study patients suffering from these diseases. The overall aim of the study is to improve the understanding, diagnosis, prognosis, recognition and management of patients with mastocytosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with mast cell diseases, managed in France in a rare disease reference center CEREMAST.\n\n13000 pateints estimated.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children from birth and adults of any age\n2. With one of the following mast cell diseases:\n\n * Mastocytoses (cutaneous, systemic and sarcomas) Defined according to the WHO 2016 classification\n * Mast cell activation syndromes (idiopathic, secondary and clonal)\n * Other mast cell activation disorders (MCAD-NOS), Defined according to the Vienna classification\n * Pre-mastocytosis or MMC (1 to 2 criteria according to WHO 2016 classification).\n3. Managed in France in a rare disease reference, constitutive or competence center (CEREMAST) with DGOS labelization.\n\nExclusion Criteria:\n\n1\\. Opposition of the patient or his/her parents to participation in the study.'}, 'identificationModule': {'nctId': 'NCT06186856', 'acronym': 'DATAMAST', 'briefTitle': 'Epidemiological Data on Mast Cell Pathologies in France', 'organization': {'class': 'OTHER', 'fullName': 'Imagine Institute'}, 'officialTitle': 'Epidemiological Data on Mast Cell Pathologies in France', 'orgStudyIdInfo': {'id': 'HJ-22-DATAMAST'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clément GOURGUECHON, Dr', 'role': 'CONTACT', 'email': 'Gourguechon.Clement@chu-amiens.fr', 'phone': '+33 (0)3 22 45 59 14'}, {'name': 'Clément GOURGUECHON, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU AMIENS site sud', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49100', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christian Lavigne, Dr', 'role': 'CONTACT', 'email': 'ChLavigne@chu-angers.fr', 'phone': '+33 (0)2 41 35 36 37'}, {'name': 'Christian Lavigne, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florence CASTELAIN, Dr', 'role': 'CONTACT', 'email': 'fcastelain@chu-besancon.fr', 'phone': '+33 (0)3 81 21 80 97'}, {'name': 'Florence CASTELAIN, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu - Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '14033', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gandhi DAMAJ, Pr', 'role': 'CONTACT', 'email': 'damaj-gl@chu-caen.fr', 'phone': '+33 (0)2 31 27 21 07'}, {'name': 'Yann OLLIVIER, Dr', 'role': 'CONTACT', 'email': 'ollivier-y@chu-caen.fr'}, {'name': 'Gandhi DAMAJ, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yann OLLIVIER, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chu - Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier TOURNILHAC, Pr', 'role': 'CONTACT', 'email': 'otournilhac@chu-clermontferrand.fr', 'phone': '+33 (0)4 73 75 00 74'}, {'name': 'Olivier TOURNILHAC, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu - Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '38700', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurence BOUILLET, Pr', 'role': 'CONTACT', 'email': 'lbouillet@chu-grenoble.fr'}, {'name': 'Laurence BOUILLET, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David LAUNAY, Pr', 'role': 'CONTACT', 'email': 'david.launay@chru-lille.fr', 'phone': '+33 (0)3 20 44 42 96'}, {'name': 'David LAUNAY, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chru Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87000', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Pierre GOURIN, Dr', 'role': 'CONTACT', 'email': 'marie-pierre.gourin@chu-limoges.fr', 'phone': '+33 (0)5 55 05 66 42'}, {'name': 'Marie-Pierre GOURIN, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu - Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maël Heiblig, Dr', 'role': 'CONTACT', 'email': 'mael.heiblig@chu-lyon.fr'}, {'name': 'Maël Heiblig, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13005', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline GAUDY, Pr', 'role': 'CONTACT', 'email': 'Caroline.GAUDY@ap-hm.fr', 'phone': '+33 (0)1 43 27 01 56'}, {'name': 'Caroline GAUDY, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu - La Timone - Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34090', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe GUILPAIN, Pr', 'role': 'CONTACT', 'email': 'P-guilpain@chu-montpellier.fr'}, {'name': 'Philippe GUILPAIN, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54035', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Roland JAUSSAUD, Pr', 'role': 'CONTACT', 'email': 'R.JAUSSAUD@chru-nancy.fr', 'phone': '+33 (0)3 83 15 41 43.'}, {'name': 'Roland JAUSSAUD, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de NANCY', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44000', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine NEEL, Pr', 'role': 'CONTACT', 'email': 'antoine.neel@chu-nantes.fr', 'phone': '+33 (0)2 40 08 33 55'}, {'name': 'Antoine NEEL, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu - Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stephane Barete, Dr', 'role': 'CONTACT', 'email': 'stephane.barete@aphp.fr', 'phone': '+33 (0)1 42 16 10 58'}, {'name': 'Stephane Barete, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Universitaire Pitié Salpetrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien Rossignol, Dr', 'role': 'CONTACT', 'email': 'julien.rossignol@aphp.fr', 'phone': '+33 (0)1 44 49 40 00'}, {'name': 'Hassiba Bouktit', 'role': 'CONTACT', 'email': 'hassiba.bouktit@aphp.fr', 'phone': '+33 (0)1 44 49 53 31'}, {'name': 'Julien Rossignol, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Olivier Hermine, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Necker-Enfants malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35000', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Edwige LE MOUEL, Dr', 'role': 'CONTACT', 'email': 'edwige.le.mouel@chu-rennes.fr', 'phone': '+33 (0)2 99 26 71 28'}, {'name': 'Edwige LE MOUEL, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu - Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '97448', 'city': 'Saint-Pierre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Quentin CABRERA, Dr', 'role': 'CONTACT', 'email': 'quentin.cabrera@chu-reunion.fr', 'phone': '262 (0)262 35 91 78'}, {'name': 'Quentin CABRERA, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Réunion sud - Saint Pierre', 'geoPoint': {'lat': 43.29282, 'lon': 5.40682}}, {'zip': '67200', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rose-Marie JAVIER, Dr', 'role': 'CONTACT', 'email': 'rose-marie.javier@chru-strasbourg.fr', 'phone': '+33 (0)3 88 11 67 68'}, {'name': 'Rose-Marie JAVIER, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chru - Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '40031', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cristina LIVIDEANU, Dr', 'role': 'CONTACT', 'email': 'livideanu.c@chu-toulouse.fr'}, {'name': 'Cristina LIVIDEANU, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37000', 'city': 'Tours', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cyrille HOARAU, Dr', 'role': 'CONTACT', 'email': 'hoarau_c@med.univ-tours.fr'}, {'name': 'Cyrille HOARAU, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de TOURS', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Julien Rossignol, Dr', 'role': 'CONTACT', 'email': 'julien.rossignol@aphp.fr', 'phone': '+33 (0)1 44 49 40 00'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imagine Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}