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Trial record 17 of 21 for:    PROPRANOLOL AND Infantile Hemangioma

Evaluation of New Biomarkers Predictive of Efficacy Betablockers in PEComa and Vascular Pediatric Tumors (PEC-Hem)

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ClinicalTrials.gov Identifier: NCT02334930
Recruitment Status : Completed
First Posted : January 8, 2015
Last Update Posted : August 22, 2016
Sponsor:
Collaborators:
Ministry for Health and Solidarity, France
National Cancer Institute, France
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:

PEComa is rare tumor affecting particularly patients with Tuberous Sclerosis. Biological similarities were seen between PEComa and infantile hemangioma. Propranolol is highly efficient to treat infantile hemangioma and we believe that this drug can also be useful for the treatment of PEComa.

Purpose : to understand the mechanism of action of propranolol in PEComas and related pediatric vascular lesions and to select possible novel targets of betablockers in vascular tumors related to PEComas by using YAP oncogene activation as a molecular marker


Condition or disease Intervention/treatment
PEComa Hemangioma Other: Biopsy

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Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of New Biomarkers Predictive of Efficacy Betablockers in PEComa and Vascular Pediatric Tumors
Study Start Date : April 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks

Group/Cohort Intervention/treatment
Patients
Patients who will have biopsy or surgery for Perivascular epithelioid cell tumor (PEComa) or vascular pediatric tumor (Rapidly Involuting Congenital Hemangioma (RICH), Non Involuting Congenital Hemangioma (NICH), hemangioma or pyogenic granuloma)
Other: Biopsy



Primary Outcome Measures :
  1. YAP cellular expression by immunohistochemistry study on collected tissues [ Time Frame: At inclusion (day 0)] ]

Secondary Outcome Measures :
  1. Beta adrenergic receptors expression by immunohistochemistry study on collected tissues [ Time Frame: At inclusion (day 0)] ]
  2. Study of Hippo/YAP pathway expression by western-blot, and correlation with propranolol efficacy [ Time Frame: At inclusion (day 0)] ]
  3. Study of MAP/kinases pathway expression by western-blot, and correlation with propranolol efficacy [ Time Frame: At inclusion (day 0)] ]
  4. Study of PKA/AMPc pathway expression by western-blot, and correlation with propranolol efficacy [ Time Frame: At inclusion (day 0)] ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who will have biopsy or surgery for PEComa or vascular pediatric tumor (RICH, NICH, hemangioma or pyogenic granuloma)
Criteria

Inclusion Criteria:

  • patients who will have biopsy or surgery for PEComa or vascular pediatric tumor (RICH, NICH, hemangioma or pyogenic granuloma)
  • A free, informed and written consent will be established

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334930


Locations
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France
CHU de Bordeaux
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry for Health and Solidarity, France
National Cancer Institute, France

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02334930     History of Changes
Other Study ID Numbers: CHUBX 2013/34
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016
Keywords provided by University Hospital, Bordeaux:
propranolol
betablocker
angiogenesis
Additional relevant MeSH terms:
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Hemangioma
Perivascular Epithelioid Cell Neoplasms
Neoplasms
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs