NCT01206673

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

December 2, 2011

Status Verified

December 1, 2011

Enrollment Period

1.6 years

First QC Date

September 21, 2010

Last Update Submit

December 1, 2011

Conditions

Patients With Gaucher's Disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Blood samplingOTHER

One blood sampling is required for the research

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Children (age\<18)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nantes Hospital

Nantes, 44093, France

Location

CHU of Rennes

Rennes, 35, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2010

First Posted

September 22, 2010

Study Start

December 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 2, 2011

Record last verified: 2011-12

Locations

FR(2)