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Spots Global Cancer Trial Database for Hemangioma Associated With High Rates of Morbidity

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Trial Identification

Brief Title: Hemangioma Associated With High Rates of Morbidity

Official Title: Hemangioma Associated With High Rates of Morbidity:A Prospective Study

Study ID: NCT00394888

Conditions

Hemangioma

Study Description

Brief Summary: We are conducting a study on the possible presence of PHACES in children with large facial hemangiomas and lumbosacral hemangiomas of infancy (hemangioma in the lower back) . With this study we hope to better understand the risk of this syndrome and to develop guidelines for its evaluation and management.

Detailed Description: Large hemangiomas of the face can be associated with anomalies of the blood vessels of head and chest. The acronym PHACES indicates the association of Posterior fossa and other brain malformations, facial Hemangioma, Arterial anomalies, Coarctation of the aorta and other cardiac defects, Eye abnormalities and Sternal malformations. Study subjects will be recruited through the Pediatric Dermatology department in several cities. All patients age 0-1 year old of age, who present with large facial hemangioma (\>22 cm\^2) will be offered to participate in the study. Parents will be interviewed to obtain personal, medical, and family history. Patients will undergo standard of care evaluation for facial hemangioma with risk of PHACE syndrome. This includes skin, eye and neurological examination, photograph, magnetic resonance imaging (MRI) of head/neck/chest, and lab tests requiring samples of blood, urine or stool. No other tests will be performed for participating in the study. Lumbosacral hemangiomas of infancy (hemangioma in the lower back) can be associated with anomalies of the spine. "Tethered cord syndrome" indicates a condition caused by abnormally stretched spinal cord. Over time this condition can lead to neurological damage. Although often there are no symptoms until adulthood, it can become apparent during childhood. Common symptoms are: lower back pain, pain and weakness of the legs, walking problems, and bladder and bowel loss of control. "Occult spinal dysraphism" is the term used when the defect of the spine is hidden under normal skin. We noticed that infants with hemangioma in the lower back area are more inclined to present a hidden spine defect. Study subjects will be recruited through the Pediatric Dermatology departments in several cities. All patients age 0-18 year old of age, who present with lumbosacral hemangioma (\> 2.5 cm of diameter overlying the spine) will be offered to participate in the study. Parents will be interviewed to obtain personal, medical, and family history. Patients will undergo standard of care evaluation for lumbosacral hemangioma. This includes skin, neurological examination, photograph, magnetic resonance imaging (MRI) of the back, lab tests requiring samples of blood, urine or stool. No additional tests will be performed only for participating in the study.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Beth Drolet, MD, Milwaukee, Wisconsin, United States

Contact Details

Name: Beth Drolet, MD

Affiliation: Medical College of Wisconsin

Role: PRINCIPAL_INVESTIGATOR

Name: Maria Garzon, MD

Affiliation: Columbia University

Role: PRINCIPAL_INVESTIGATOR

Name: Denise Metry, MD

Affiliation: Baylor College of Medicine

Role: PRINCIPAL_INVESTIGATOR

Name: Ilona Frieden, MD

Affiliation: University of California, San Francisco

Role: PRINCIPAL_INVESTIGATOR

Name: Julie Powell, MD

Affiliation: Hopital Sainte-Justine

Role: PRINCIPAL_INVESTIGATOR

Name: Anne Lucky, MD

Affiliation: Children's Hospital of Cincinnati

Role: PRINCIPAL_INVESTIGATOR

Name: Sharon Glick, MD

Affiliation: State University of New York - Downstate Medical Center

Role: PRINCIPAL_INVESTIGATOR

Name: Eulalia Baselga, MD

Affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Role: PRINCIPAL_INVESTIGATOR

Name: Anita Haggstrom, M.D.

Affiliation: Indiana University

Role: PRINCIPAL_INVESTIGATOR

Name: Anthony Mancini, MD

Affiliation: Northwestern University

Role: PRINCIPAL_INVESTIGATOR

Name: Kimberly Horii, MD

Affiliation: Children's Mercy Hospital Kansas City

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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