Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-26 @ 7:46 PM
Study NCT ID:
NCT00374335
Status:
COMPLETED
Last Update Posted:
2011-09-16
First Post:
2006-09-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006391', 'term': 'Hemangioma'}], 'ancestors': [{'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kahorii@cmh.edu', 'phone': '816-234-3924', 'title': 'Dr. Kimberly Horii', 'organization': "Children's Mercy Hospitals and Clinics"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'Cutaneous Hemangiomas (multiple \\> 5, 1-4, or at least 1 hemangioms \\>30 cm2)', 'otherNumAtRisk': 261, 'otherNumAffected': 0, 'seriousNumAtRisk': 261, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Cutaneous Hemangiomas (multiple \\> 5, 1-4, or at least 1 hemangioms \\>30 cm2)'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Risk Factors Associated With the Development of Hepatic Hemangiomas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Cutaneous Hemangiomas (multiple \\> 5, 1-4, or at least 1 hemangioms \\>30 cm2)'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Which participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least 1 large cutaneous hemangioma) were found to have hepatic hemangiomas on abdominal ultrasound', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Presence of Hepatic Hemangiomas on Abdominal Ultrasound', 'timeFrame': '2 years', 'description': 'The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'Cutaneous Hemangiomas (multiple \\> 5, 1-4, or at least 1 hemangioms \\>30 cm2)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '261'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '261'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Cutaneous Hemangiomas (multiple \\> 5, 1-4, or at least 1 hemangioms \\>30 cm2)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '261', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '192', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '232', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 261}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-12', 'studyFirstSubmitDate': '2006-09-07', 'resultsFirstSubmitDate': '2011-08-09', 'studyFirstSubmitQcDate': '2006-09-08', 'lastUpdatePostDateStruct': {'date': '2011-09-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-09', 'studyFirstPostDateStruct': {'date': '2006-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound', 'timeFrame': '2 years', 'description': 'The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound'}, {'measure': 'Presence of Hepatic Hemangiomas on Abdominal Ultrasound', 'timeFrame': '2 years', 'description': 'The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound'}], 'secondaryOutcomes': [{'measure': 'Risk Factors Associated With the Development of Hepatic Hemangiomas', 'timeFrame': '2 years', 'description': 'Which participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least 1 large cutaneous hemangioma) were found to have hepatic hemangiomas on abdominal ultrasound'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prospective cohort study'], 'conditions': ['Hemangioma']}, 'referencesModule': {'references': [{'pmid': '12472344', 'type': 'BACKGROUND', 'citation': 'Chiller KG, Passaro D, Frieden IJ. Hemangiomas of infancy: clinical characteristics, morphologic subtypes, and their relationship to race, ethnicity, and sex. Arch Dermatol. 2002 Dec;138(12):1567-76. doi: 10.1001/archderm.138.12.1567.'}, {'pmid': '8804322', 'type': 'BACKGROUND', 'citation': 'Boon LM, Burrows PE, Paltiel HJ, Lund DP, Ezekowitz RA, Folkman J, Mulliken JB. Hepatic vascular anomalies in infancy: a twenty-seven-year experience. J Pediatr. 1996 Sep;129(3):346-54. doi: 10.1016/s0022-3476(96)70065-3.'}, {'pmid': '15148105', 'type': 'BACKGROUND', 'citation': 'Metry DW, Hawrot A, Altman C, Frieden IJ. Association of solitary, segmental hemangiomas of the skin with visceral hemangiomatosis. Arch Dermatol. 2004 May;140(5):591-6. doi: 10.1001/archderm.140.5.591.'}, {'pmid': '15037141', 'type': 'BACKGROUND', 'citation': 'Hughes JA, Hill V, Patel K, Syed S, Harper J, De Bruyn R. Cutaneous haemangioma: prevalence and sonographic characteristics of associated hepatic haemangioma. Clin Radiol. 2004 Mar;59(3):273-80. doi: 10.1016/S0009-9260(03)00267-8.'}, {'pmid': '12664009', 'type': 'BACKGROUND', 'citation': 'Bruckner AL, Frieden IJ. Hemangiomas of infancy. J Am Acad Dermatol. 2003 Apr;48(4):477-93; quiz 494-6. doi: 10.1067/mjd.2003.200.'}, {'pmid': '20157038', 'type': 'DERIVED', 'citation': 'Horii KA, Drolet BA, Baselga E, Frieden IJ, Metry DW, Morel KD, Newell BD, Nopper AJ, Garzon MC; Hemangioma Investigator Group. Risk of hepatic hemangiomas in infants with large hemangiomas. Arch Dermatol. 2010 Feb;146(2):201-3. doi: 10.1001/archdermatol.2009.391. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This study will attempt to determine how common liver hemangiomas are in children with infantile hemangiomas by comparing liver ultrasound results in patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma versus ultrasound results in children without hemangiomas. Other objectives of the study include identifying specific risk factors in patients who have liver hemangiomas and identifying risk factors in children with symptomatic liver hemangiomas.', 'detailedDescription': 'Hemangioma of infancy is the most common tumor of childhood occurring in 4% to 10% of infants. While most hemangiomas are benign in behavior and involute spontaneously, some can cause significant morbidity due to their location and size. In addition, some hemangiomas may be associated with extracutaneous hemangiomas that result in significant morbidity. Certain "high risk" hemangiomas of infancy, specifically multiple cutaneous hemangiomas or a solitary large hemangioma, have been associated with hepatic hemangiomatosis; however, the exact number or size of the cutaneous lesions at which the risk increases and the protocol for evaluating these patients remain controversial. The true prevalence of hepatic hemangiomatosis is unknown since there have been no large scale prospective studies evaluating clinically asymptomatic patients with cutaneous hemangiomas for the presence of hepatic hemangiomatosis.\n\nOne of the primary objectives of this study is to determine the incidence of hepatic hemangiomatosis in patients with hemangiomas of infancy by comparing hepatic ultrasound imaging results of patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma \\>30 cm2 versus imaging results in patients without cutaneous hemangiomas. The study will also attempt to identify specific risk factors associated with the development of hepatic hemangiomatosis and to identify associated risk factors in patients with clinically symptomatic hepatic hemangiomatosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants less than 6 months of age\n* clinical diagnosis of 1-4 cutaneous hemangiomas\n* clinical diagnosis of 5 or more cutaneous hemangiomas\n* clinical diagnosis of at least 1 large cutaneous hemangioma greater than 30 cm2\n\nExclusion Criteria:\n\n* Infants greater than 6 months of age'}, 'identificationModule': {'nctId': 'NCT00374335', 'briefTitle': 'Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Multiple Hemangiomas and Large Cutaneous Hemangiomas of Infancy: Incidence of Hepatic Hemangiomatosis', 'orgStudyIdInfo': {'id': '06 02 029E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'infants with cutaneous hemangiomas', 'interventionNames': ['Procedure: abdominal ultrasound', 'Other: Dermatologic Examination']}], 'interventions': [{'name': 'abdominal ultrasound', 'type': 'PROCEDURE', 'description': 'abdominal ultrasound to detect hepatic hemangiomas', 'armGroupLabels': ['infants with cutaneous hemangiomas']}, {'name': 'Dermatologic Examination', 'type': 'OTHER', 'description': 'Complete dermatologic examination', 'armGroupLabels': ['infants with cutaneous hemangiomas']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Beth A Drolet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}, {'name': 'Maria Garzon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Kimberly A Horii, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}, {'name': 'Denise Metry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}, {'name': 'Sarah Chamlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Northwestern University-Children's Memorial Hospital"}, {'name': 'Ilona J Frieden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Julie Powell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Justine's Hospital"}, {'name': 'Anne Lucky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Cincinnati"}, {'name': 'Eulalia Baselga, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de la Santa Crue i Santa Pau'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'Northwestern University', 'class': 'OTHER'}, {'name': "St. Justine's Hospital", 'class': 'OTHER'}, {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}