- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00374335
Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas
Multiple Hemangiomas and Large Cutaneous Hemangiomas of Infancy: Incidence of Hepatic Hemangiomatosis
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
One 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Infants less than 6 months of age
- clinical diagnosis of 1-4 cutaneous hemangiomas
- clinical diagnosis of 5 or more cutaneous hemangiomas
- clinical diagnosis of at least 1 large cutaneous hemangioma greater than 30 cm2
Exclusion Criteria:
- Infants greater than 6 months of age
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: infants with cutaneous hemangiomas
|
abdominal ultrasound to detect hepatic hemangiomas
Complete dermatologic examination
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound
Tidsramme: 2 years
|
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
|
2 years
|
Presence of Hepatic Hemangiomas on Abdominal Ultrasound
Tidsramme: 2 years
|
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
|
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Risk Factors Associated With the Development of Hepatic Hemangiomas
Tidsramme: 2 years
|
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
|
2 years
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Maria Garzon, MD, Columbia University
- Ledende efterforsker: Denise Metry, MD, Baylor College of Medicine
- Ledende efterforsker: Anne Lucky, MD, Children's Hospital of Cincinnati
- Ledende efterforsker: Ilona J Frieden, MD, University of California, San Francisco
- Ledende efterforsker: Kimberly A Horii, MD, Children's Mercy Hospital Kansas City
- Ledende efterforsker: Sarah Chamlin, MD, Northwestern University-Children's Memorial Hospital
- Ledende efterforsker: Julie Powell, MD, St. Justine's Hospital
- Ledende efterforsker: Eulalia Baselga, MD, Hospital de la Santa Crue i Santa Pau
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 06 02 029E
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