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Phenotypic Expressions in a French Pseudoxanthoma-Elasticum Cohort

This study is currently recruiting participants.
Verified October 2009 by University Hospital, Angers
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01446380
First received: February 3, 2010
Last updated: October 3, 2011
Last verified: October 2009
History of Changes
  Purpose

The cohort is intended to study the phenotypic expressions of the pseudoxanthoma elasticum (PXE) disease in various tissues (eye, skin, arteries, etc).


Condition
Pseudoxanthoma Elasticum

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phenotypic Expressions in a French Pseudoxanthoma-Elasticum Cohort

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Angers:

Biospecimen Retention:   Samples With DNA

Sera,Plasma,DNA,skin biopsy


Estimated Enrollment: 350
Study Start Date: June 2008
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pseudoxanthoma elasticum

Detailed Description:

This national french cohort is intended to improve our knowledge on the PXE disease. The study of phenotypic expression of the diseases is focused on cutaneous, opthalmologic and vascular tissues. All investigations are included in a yearly follow-up for these patients and collected in a database.

Plasma are also collected for all patients and stored in our clinical research biological center in Angers, including genetic (DNA) material extracted from diagnostic skin biopsy. French Ministry of Teaching and Research Authorisation number for the PXE collection is AC 2008 871. Declarative number is DC 2008 870.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed for a PXE disease from any part of France and requesting a follow-up and clinical management of there disease (opthalmic and vascular complications mainly).

Criteria

Inclusion Criteria:

  • Patients with PXE disease
  • Informed consent obtained
  • Patient affiliated to Health care system (french social security)

Exclusion Criteria:

  • No informed consent
  • No affiliation to a Health care system
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446380

Contacts
Contact: Ludovic MARTIN, MD PhD 33(2)41-35-34-19 LuMartin@chu-angers.fr
Contact: Georges LEFTHERIOTIS, MD-PHD 33(2)41-35-44-56 GeLeftheriotis@chu-angers.fr

Locations
France
University Hospital of Angers Recruiting
Angers, Pays de Loire, France, 49933
Contact: Ludovic MARTIN, MD-PhD     33(0)2-41-35-34-19     LuMartin@chu-angers.fr    
Contact: Georges LEFTHERIOTIS, MD-PhD     33(0)2-41-35-44-56     GeLeftheriotis@chu-angers.fr    
Sub-Investigator: Georges LEFTHERIOTIS, MD-PHD            
Sub-Investigator: Pierre ABRAHAM, MD-PHD            
Sub-Investigator: Fabrice PRUNIER, MD-PHD            
Sub-Investigator: Jean Marc EBRAN, MD            
Sponsors and Collaborators
University Hospital, Angers
Investigators
Study Director: Ludovic MARTIN, MD PhD UH Angers
  More Information

Publications:

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01446380     History of Changes
Other Study ID Numbers: AC 2008 871
Study First Received: February 3, 2010
Last Updated: October 3, 2011
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Pseudoxanthoma Elasticum
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
 Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013