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OpenTrials
Completed

NCT Number: NCT02334930

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

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

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Key information

Conditions

PEComa Hemangioma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Vascular Tissue Perivascular Epithelioid Cell Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux

Bordeaux, 33000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy

Other

Primary outcomes

  1. YAP cellular expression by immunohistochemistry study on collected tissues

    Time frame: At inclusion (day 0)]

Secondary outcomes

  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)]

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Ministry for Health and Solidarity, France
  • National Cancer Institute, France

Registry information

Acronym: PEC-Hem

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 8, 2015
Registry last updated
Aug 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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