Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT02811705
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2016-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Life Quality Study for PFAPA Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536025', 'term': 'Marshall syndrome'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare quality of life from patients with PFAPA and FMF, reported by parents and by patients themselves', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Evaluate the fatigue status of patients through questionnaire PedsQL TM 3.0 multidimensional scale tiredness', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['PFAPA Syndrome']}, 'descriptionModule': {'briefSummary': 'This cohort study aims to assess the quality of life (or welfare) related to the health of children and adolescents with an non genetics auto-inflammatory disease PFAPA or Marshall syndrome to compare it to children or adolescents with recurrent fever genetics of Familial Mediterranean fever (FMF) in order to improve their overall care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with PFAPA syndrome compare to patient with FMF syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PFAPA syndrome patients or FMF patients\n\nExclusion Criteria:\n\n* Participation refusal'}, 'identificationModule': {'nctId': 'NCT02811705', 'acronym': 'PFAPA', 'briefTitle': 'Life Quality Study for PFAPA Patient', 'organization': {'class': 'OTHER', 'fullName': 'Versailles Hospital'}, 'orgStudyIdInfo': {'id': 'P15/13_PFAPA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PFAPA group', 'description': 'Life quality for PFAPA patient report by themselves or parent', 'interventionNames': ['Other: Quality of life']}, {'label': 'FMF group', 'description': 'Life quality for FMF patient report by themselves or parent', 'interventionNames': ['Other: Quality of life']}], 'interventions': [{'name': 'Quality of life', 'type': 'OTHER', 'description': 'Quality of life', 'armGroupLabels': ['FMF group', 'PFAPA group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Le Chesnay', 'country': 'France', 'facility': 'Centre hospitalier de Versailles', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'city': 'Paris', 'country': 'France', 'facility': 'CH de Bicètre', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Versailles Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Véronique Hentgen', 'investigatorAffiliation': 'Versailles Hospital'}}}}