Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT05488561
Status:
UNKNOWN
Last Update Posted:
2022-08-04
First Post:
2022-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Molecular Evaluation of Childern With Familial Meditterranean Fever and Their Siblings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-03', 'releaseDate': '2024-07-01'}], 'estimatedResultsFirstSubmitDate': '2024-07-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010505', 'term': 'Familial Mediterranean Fever'}], 'ancestors': [{'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001772', 'term': 'Blood Cell Count'}, {'id': 'D007677', 'term': 'Kidney Function Tests'}], 'ancestors': [{'id': 'D002452', 'term': 'Cell Count'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-03', 'studyFirstSubmitDate': '2022-08-03', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CBC', 'timeFrame': '12 month', 'description': 'leucocytosis'}, {'measure': 'amyloid level', 'timeFrame': '12 month', 'description': 'high in untreated patients'}, {'measure': 'FMF gene', 'timeFrame': '12 month', 'description': 'positive or negative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Familial Mediterranean Fever']}, 'referencesModule': {'references': [{'pmid': '28624931', 'type': 'BACKGROUND', 'citation': 'Alghamdi M. Familial Mediterranean fever, review of the literature. Clin Rheumatol. 2017 Aug;36(8):1707-1713. doi: 10.1007/s10067-017-3715-5. Epub 2017 Jun 18.'}, {'pmid': '31524848', 'type': 'BACKGROUND', 'citation': 'Cakan M, Karadag SG, Tanatar A, Sonmez HE, Ayaz NA. The Value of Serum Amyloid A Levels in Familial Mediterranean Fever to Identify Occult Inflammation During Asymptomatic Periods. J Clin Rheumatol. 2021 Jan 1;27(1):1-4. doi: 10.1097/RHU.0000000000001134.'}, {'pmid': '30686512', 'type': 'BACKGROUND', 'citation': 'Ozdogan H, Ugurlu S. Familial Mediterranean Fever. Presse Med. 2019 Feb;48(1 Pt 2):e61-e76. doi: 10.1016/j.lpm.2018.08.014. Epub 2019 Jan 25.'}, {'pmid': '32676558', 'type': 'BACKGROUND', 'citation': 'Talaat HS, Sheba MF, Mohammed RH, Gomaa MA, Rifaei NE, Ibrahim MFM. Genotype Mutations in Egyptian Children with Familial Mediterranean Fever: Clinical Profile, and Response to Colchicine. Mediterr J Rheumatol. 2020 Jun 15;31(2):206-213. doi: 10.31138/mjr.31.2.206. eCollection 2020 Jun.'}]}, 'descriptionModule': {'briefSummary': "Familial Mediterranean fever (FMF ,recurrent polyserositis ,periodic disease) is an autosomal recessive auto inflammatory disease which primarily affect population surrounding the Mediterranean basin (Arabs , Turks ,Armenians, Jews ).Despite its striking symptoms pattern FMF was first described as distinct entity only in 1945.\n\nIt is characterized by recurrent attacks of fever , peritonitis ,pleurisy , arthritis , or erysipelas like skin disease. The most dangerous complication of this disease is secondary amyloidosis . FMF diagnosis is mainly clinical, and the genetic testing is indicated to support it . Uncommonly, amyloidosis may develop in individuals carrying two Familial Mediterranean fever gene (MEFV ) mutations without overt clinical symptoms of FMF, a condition designated as phenotype II. Furthermore, two MEFV mutations may be harbored without signs or symptoms of FMF nor of reactive amyloidosis. This 'silent' homozygous or compound heterozygote state is termed phenotype III."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA- all children diagnosed as FMF according to Tel hashomer criteria aged below 18 years:\n\nThe presence of at least 2 of the following 5 criteria after exclusion of other causes can diagnose FMF with high sensitivity:\n\n1. Fever axillary temperature of \\>38ᵒC, 6-72 h of duration, ≥3 attacks\n2. Abdominal pain 6-72 h of duration ≥3 attacks\n3. Chest pain 6-72 h duration≥ 3 attacks\n4. Arthritis 6-72 h duration ≥3 attacks, oligoarthritis\n5. Family history of FMF\\*(11) B-sisters and brothers of a child with FMF with clinical or subclinical manifestation of FMF.\n\nExclusion Criteria:\n\n1. Children with other auto inflammatory diseases, or with other diseases.\n2. Persons above 18 years old.'}, 'identificationModule': {'nctId': 'NCT05488561', 'briefTitle': 'Clinical and Molecular Evaluation of Childern With Familial Meditterranean Fever and Their Siblings', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Clinical and Molecular Evaluation of Childern With Familial Meditterranean Fever and Their Siblings', 'orgStudyIdInfo': {'id': 'Soh_Med_22_07_20'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CBC with differential ,ESR ,CRP, Amyloid level , FMF gene', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['liver and kidney function tests'], 'description': 'leucocytosis , high ESR and CRP ,amyloid level indicates inflammation positive FMF gene indicates having the disease .'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Osama R Elshrif, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'nahla a fawy, resident', 'role': 'CONTACT', 'email': 'nahlaabdelaziz@med.sohag.edu.eg', 'phone': '01015681398'}, {'name': 'ashraf m redwan, assisstant professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at pediatric department at faculty of medicine sohag university hospital', 'investigatorFullName': 'Nahla Abdelziz Fawy', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-07-01', 'type': 'RELEASE'}, {'date': '2024-10-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Nahla Abdelziz Fawy, resident doctor at pediatric department at faculty of medicine sohag university hospital, Sohag University'}}}}