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Macrophagic Activation and Immunophenotypic Profile of Patients With Gaucher's Disease (Gaucher)

Primary Purpose

Patients With Gaucher's Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Patients With Gaucher's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults (age equal or above 18.
  • Patients with Gaucher 's disease treated in the "Grand Ouest" competence center
  • patients affiliated to social security
  • Informed consent signed

Exclusion Criteria:

- Children (age<18)

Sites / Locations

  • Nantes Hospital
  • CHU of Rennes

Outcomes

Primary Outcome Measures

To determine the implication of acquired and inherent immunity in the Gaucher's clinical phenotype at moment of blood sampling

Secondary Outcome Measures

to find new activity mark for Gaucher's disease by studying macrophagic activation's markers.

Full Information

First Posted
September 21, 2010
Last Updated
December 1, 2011
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01206673
Brief Title
Macrophagic Activation and Immunophenotypic Profile of Patients With Gaucher's Disease
Acronym
Gaucher
Official Title
Evaluation of Macrophagic Activation and Immunophenotypic Profile of Patients With Gaucher's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate macrophaging activity and immunologic profile of patients with Gaucher 's disease. For this, one blood sampling will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Gaucher's Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
One blood sampling is required for the research
Primary Outcome Measure Information:
Title
To determine the implication of acquired and inherent immunity in the Gaucher's clinical phenotype at moment of blood sampling
Secondary Outcome Measure Information:
Title
to find new activity mark for Gaucher's disease by studying macrophagic activation's markers.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (age equal or above 18. Patients with Gaucher 's disease treated in the "Grand Ouest" competence center patients affiliated to social security Informed consent signed Exclusion Criteria: - Children (age<18)
Facility Information:
Facility Name
Nantes Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU of Rennes
City
Rennes
ZIP/Postal Code
35
Country
France

12. IPD Sharing Statement

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Macrophagic Activation and Immunophenotypic Profile of Patients With Gaucher's Disease

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