Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT07189832
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2025-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bleomycin Intralesional Injections of Cystic Hygromas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044148', 'term': 'Lymphatic Abnormalities'}, {'id': 'D018191', 'term': 'Lymphangioma, Cystic'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008202', 'term': 'Lymphangioma'}, {'id': 'D018190', 'term': 'Neoplasm, Lymphatic Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015552', 'term': 'Injections, Intralesional'}], 'ancestors': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'pediatric patients of age up to 12 years having Cervicofacial cystic hygromas'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2025-09-22', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement', 'timeFrame': '6 months', 'description': 'change of lesion size'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bleomycin, Cervico-facial, Cystic Hygroma, Lymphatic Malformation'], 'conditions': ['Lymphatic Malformations']}, 'descriptionModule': {'briefSummary': 'Thirty pediatric patients with cystic hygromas participated in this study. The cystic fluid was aspirated from the cystic hygroma, and the lesion was simultaneously injected with Bleomycin. Then, the lesion was re-injected at 4-week intervals until satisfactory results were obtained. Clinical response was evaluated as complete response (\\> 90% reduction of lesion size), marked improvement (\\>70% reduction of lesion size), moderate improvement (40 - 70% reduction of lesion size), slight improvement (\\< 40%), and no response (\\< 10% reduction of lesion size).', 'detailedDescription': 'A total of 30 pediatric patients of age up to 12 years having Cervicofacial cystic hygromas (macrocystic lymphatic malformations) were chosen from the vascular anomalies clinic in Cairo University Specialized Pediatric Hospital (CUSPH). Diagnosis was accomplished by taking history from parents, clinical examination, and confirmed by ultrasonography (USG) and\\\\or magnetic resonance imaging (MRI) for deep lesions.\n\nThe procedure was explained in simple, clear words to the parents of each infant/child before the study, and an informed written consent was signed by each parent, containing treatment benefits, potential risks as outlined in the principles of Helsinki Declaration. Each infant/child was treated and followed up for 12 months after the last BLM intralesional injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Month', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of Cervicofacial cystic hygromas (macrocystic lymphatic malformations) Pediatric patients from age 1 month to 12 years, recruited from the vascular anomalies clinic at the pediatric surgery department in Cairo University Specialized Pediatric Hospital (Abu EL-Reesh hospital).\n\nExclusion Criteria:\n\nlung disease cardiac disease Liver disease kidney disease'}, 'identificationModule': {'nctId': 'NCT07189832', 'briefTitle': 'Bleomycin Intralesional Injections of Cystic Hygromas', 'organization': {'class': 'OTHER', 'fullName': 'Delta University for Science and Technology'}, 'officialTitle': 'Bleomycin Intralesional Injections of Cystic Hygromas in Pediatric Patients', 'orgStudyIdInfo': {'id': '025081962'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intralesional Injections', 'description': 'Bleomycin Intralesional Injections', 'interventionNames': ['Procedure: Intralesional Injections']}], 'interventions': [{'name': 'Intralesional Injections', 'type': 'PROCEDURE', 'description': 'Intralesional Injections', 'armGroupLabels': ['Intralesional Injections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University Specialized Pediatric Hospital (Abu EL-Reesh hospital)', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Delta University for Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Sarah Arafat', 'investigatorAffiliation': 'Delta University for Science and Technology'}}}}