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Identification of Genetic and Cellular Markers Associated With Vascular Endothelial Modifications in Cutaneous Arteriovenous Malformations

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ClinicalTrials.gov Identifier: NCT01774916
Recruitment Status : Unknown
Verified August 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : January 24, 2013
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Cutaneous Arteriovenous malformations (AVM's) rare congenital high-flow vascular malformations in which arteries and veins are directly connected through a complex web of abnormal arteries and veins instead of a normal capillary network. Arterial feeders and enlarged draining veins directly connect through arteriovenous fistulas that create the "nidus". The natural history of AVMs is organized into a clinical staging system: during the first phase of quiescence, the arteriovenous malformation mimics a capillary malformation. After many years, the AVM may enlarge with loco-regional expansion and tissular destruction. At the ultimate stage, AVM may impact the heart function. They are considered non malignant but can expand and become a significant clinical risk when extensive. The management of these high flow AVM remains often problematic. Complete and large surgical excision of the nidus after hyperselective embolization is the only potential therapeutic solution but this, is often difficult if not impossible. There is no pathogenetic hypothesis for the development of these malformations. Histopathological examination (performed only on surgical resection specimen) is poor and does not provide sufficient evidence to assess the evolutivity or the severity of the MAV. Recent data hypothesize that these vascular malformations are associated with alterations of the vascular endothelium caused by genetic abnormalities involved in the control of angiogenesis and vascular homeostasis. The detection of these anomalies allows the search for cellular and genetic markers that might be useful to optimize the clinical classification, staging, predicting the evolution of these defects and some understanding of its pathophysiological mechanisms. To our knowledge, no studies to identify cellular markers / genetic and endothelial associated with the development of cutaneous AVMs have been published to date.

Condition or disease Intervention/treatment
Cutaneous Arteriovenous Malformations Genetic: blood samples

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Identification of Genetic and Cellular Markers Associated With Vascular Endothelial Modifications in Cutaneous Arteriovenous Malformations
Study Start Date : January 2013
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
patients Genetic: blood samples
volunter Genetic: blood samples


Outcome Measures

Primary Outcome Measures :
  1. The exploration of the microparticles, endothelial cells and progenitor cells [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. investigate the relationship between endothelial markers and genetic and clinical characteristics of the disease [ Time Frame: 36 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or feminine Subject
  • Subject of 10 and more years old,
  • Subject weighing more than 55 kg. patients:
  • Subject presenting a cutaneous artério-venous deformation there outside of any other deformation or known vascular tumor.
  • Subject presenting no other susceptible pathology to influence endothéliaux markers (Renal insufficiency, inflammatory pathology chronicles, infections, pathologies cardiovascular, diabetes, evolutionary tumoral pathology).

volunteers:

  • Unhurt Subject of deformation or vascular tumor.
  • Subject presenting no other susceptible pathology to influence endothéliaux markers(scorers) (Renal insufficiency, inflammatory pathology chronicles, infections, pathologies cardiovascular).

Exclusion Criteria:

  • Subject of less than 10 years old
  • Subject weighing less than 55 kg
  • Subject presenting another type(chap) of vascular vascular deformation or tumor
Contacts and Locations

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): NCT01774916


Contacts
Contact: Nathalie Degardin nathalie.degardin@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13006
Contact: nathalie degardin       nathalie.degardin@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: michele DAMON Assistance Publique Hopitaux De Marseille
More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01774916     History of Changes
Other Study ID Numbers: 2012-A00893-40
2012-26 ( Other Identifier: AP HM )
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Congenital Abnormalities
Arteriovenous Malformations
Hemangioma
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms