Evaluation of New Biomarkers Predictive of Efficacy Betablockers in PEComa and Vascular Pediatric Tumors

Hemangioma Clinical Trial

— PEC-Hem  

Official title:

Evaluation of New Biomarkers Predictive of Efficacy Betablockers in PEComa and Vascular Pediatric Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334930
• Other study ID #: CHUBX 2013/34
• Status: Completed
• Phase: N/A
• First received: December 22, 2014
• Last updated: August 19, 2016
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: August 2016
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemangioma
• PEComa
• Perivascular Epithelioid Cell Neoplasms

Intervention

Other:
• Biopsy

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Ministry for Health and Solidarity, France, National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	YAP cellular expression by immunohistochemistry study on collected tissues		At inclusion (day 0)]	No
Secondary	Beta adrenergic receptors expression by immunohistochemistry study on collected tissues		At inclusion (day 0)]	No
Secondary	Study of Hippo/YAP pathway expression by western-blot, and correlation with propranolol efficacy		At inclusion (day 0)]	No
Secondary	Study of MAP/kinases pathway expression by western-blot, and correlation with propranolol efficacy		At inclusion (day 0)]	No
Secondary	Study of PKA/AMPc pathway expression by western-blot, and correlation with propranolol efficacy		At inclusion (day 0)]	No