Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT03894605
Status:
UNKNOWN
Last Update Posted:
2019-03-28
First Post:
2019-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dermatological Abnormalities in Beta-thalassemia Major
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017086', 'term': 'beta-Thalassemia'}], 'ancestors': [{'id': 'D013789', 'term': 'Thalassemia'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2021-04-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2019-03-22', 'studyFirstSubmitQcDate': '2019-03-27', 'lastUpdatePostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of patients with dermatological disorders due to iron overload Iron overload cause dermatological abnormalities', 'timeFrame': 'one month', 'description': 'the number of patients who develop any dermatological disorder as a result of iron overload after frequent blood transfusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Beta-Thalassemia']}, 'referencesModule': {'references': [{'pmid': '20098328', 'type': 'BACKGROUND', 'citation': 'Cao A, Galanello R. Beta-thalassemia. Genet Med. 2010 Feb;12(2):61-76. doi: 10.1097/GIM.0b013e3181cd68ed.'}, {'pmid': '29943859', 'type': 'RESULT', 'citation': 'El-Dash H, Adel S. Cutaneous manifestations in Egyptian children with beta-thalassemia major: Relationship with serum ferritin, thyroid profile, and treatment modalities. Pediatr Dermatol. 2018 Sep;35(5):639-643. doi: 10.1111/pde.13570. Epub 2018 Jun 26.'}, {'pmid': '19785086', 'type': 'RESULT', 'citation': 'Dogramaci AC, Savas N, Ozer B, Duran N. Skin diseases in patients with beta-thalassemia major. Int J Dermatol. 2009 Oct;48(10):1057-61. doi: 10.1111/j.1365-4632.2009.04176.x.'}, {'pmid': '20997138', 'type': 'RESULT', 'citation': 'CHANG PY, KUO CL, KHOO FY. The anatomic distribution of the lesions in pulmonary tuberculosis. Med Abstr. 1945 Oct;63A:237-43. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'to study the frequency and pattern of dermatological abnormalities in egyptian childern with beta thalassemia.relationof abnormalities to duration of disease and frequency of transfusion', 'detailedDescription': 'thalassemia refers to agroup of inherited disease characterized by decreased or absent synthesis of normal globin .skinvdisorders are usually neglected and frequently underdiagnosed among these patients.skin disease specially pruritus and xerosis are observed highly frequently in patients with beta-thalassemia.pityriasis alba is arelatively common skin disorder.the trophic skin changes and leg ulcers occurred after the age of 15 years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patient examined by single dermatologist to record any dermatological abnormalities', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusio2n Criteria:\n\n* clinical diagnosis of dermatological abnormalities in thalassemic patient. must be on chelator\n\nExclusion Criteria:\n\n* patient with other hemolytic anemia. childern with any abnormalities prior to the diagnosis of thalassemi'}, 'identificationModule': {'nctId': 'NCT03894605', 'briefTitle': 'Dermatological Abnormalities in Beta-thalassemia Major', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment ofDermatological Abnrmalities in Beta-thalassemia Major in Assiut University Pediatric Hospital', 'orgStudyIdInfo': {'id': 'DBTM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'thalassemia', 'type': 'DEVICE', 'description': 'thalassemic patient use chelator and thaladssemic patient with frequent blood transfusion'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alsayed khalil Abd elkareem, Professor', 'role': 'CONTACT', 'email': 'Khalilsay@gmail.com', 'phone': '01060805170'}, {'name': 'Mostafa Mohamed, Lecturer', 'role': 'CONTACT', 'email': 'Mustafa-embaby@aun.edu.eg', 'phone': '01006244311'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Neveen Mamdoh Farag', 'investigatorAffiliation': 'Assiut University'}}}}