- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01105676
Vascular Malformations and Abnormalities of Growth
To take part in this study you/your child have a vascular malformation, a type of blood vessel disorder whose cause is unknown.
The investigators will do this by looking at changes in the genes and proteins in the cells of the malformation as well as normal cells.
The investigators are doing this research because currently there is no known cause of vascular malformations and no way to know whether or not other health problems will occur in addition to the malformation. Through this research we hope to create standard methods for doctors to examine and treat people with vascular anomalies.
Descripción general del estudio
Descripción detallada
If you/your child agree to participate
- Informed consent and permission to use or disclose you/your child's health information for reserve purposes will be obtained by the research team. You will receive a copy of the consent form.
- You/your child will be examined by a physician from the research team and interviewed about your medical background and condition every year for five years.
- You/your child will have photographs taken of the affected area at each visit.
- You/your child will have two, one time biopsies or skin samples taken by a dermatologist. Skin areas will be numbed with lidocaine and a 4 or 5 millimeter (or approximately 0.15 to 0.19 inch) sample will be taken in two different locations. The dermatologist taking the skin sample will use every effort to choose an area that can be covered by clothing or kept out of sight to others. The doctor will either use gelfoam or one stitch/suture per biopsy to seal off the area, which helps with healing and preventing bleeding. If a stitch is placed in the biopsy site, another visit about 7-10 days following the procedure will be necessary to remove the stitch.
5. You may still participate in the study if you consent to having only one biopsy taken of your affected (lesion) skin and not one of your unaffected (normal) skin.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Childrens Hospital of Wisconsin
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Greater than 1 year of age
- Diagnosis of vascular malformation
- Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation given they have the cognitive capacity to do so.
Exclusion Criteria:
- Patients less than 1 year of age
- Vascular malformations likely to result in poor wound healing or located in areas of the body prone to significant scarring
- Individuals with vascular malformations and previous diagnosis of disseminated intravascular coagulopathy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: single group single arm study
Open no masking is used.
All involved know the identity of the intervention assignment
|
Two skin biopsies will be taken one time
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Percent of growth over time
Periodo de tiempo: 5 years
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5 years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Patient specific gene and protein expression levels that can distinguish affected from unaffected tissue in patients.
Periodo de tiempo: 5 years
|
5 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kelly Duffy, MD, Children's Hospital and Health System Foundation, Wisconsin
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CHW 08/204, GC 821
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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