Back to resultsIdentification of New Markers in the Hypereosinophilic Syndrome (SHE)
Primary Purpose
Hypereosinophilic Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biologie sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypereosinophilic Syndrome
Eligibility Criteria
Inclusion Criteria:
- dated and signed informed consent
- virale serology negative or negative result less than 6 months
- virale serology negative for HBV or vaccinated patient
- insured
- virale serology negative or negative result less than 6 months
- negative pregnancy test or female menopause for at least 1 year
Exclusion Criteria:
- subject enable adult, under guardianship or under protective measures of justice
- Refusal or inability to give informed consent
- The hypereosinophilic syndrome explained origin other than than atopy, bullous pemphigoid, the Churg-Strauss syndrome and DRESS
Sites / Locations
- CHRU, Hôpital Claude Huriez
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
Hypereosinophilic syndrome unexplained
Hypereosinophilic syndrome explained
Normal rate of eosinophilic
Arm Description
Outcomes
Primary Outcome Measures
The aim is to characterize, through an approach immunoprotéomique, new HES biomarkers more informative and easier access than those currently available to us. These biomarkers will help to the diagnosis of HES, compared with other causes of eosinophilia.
Secondary Outcome Measures
Full Information
NCT ID
NCT01713504
First Posted
October 22, 2012
Last Updated
February 14, 2019
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT01713504
Brief Title
Identification of New Markers in the Hypereosinophilic Syndrome
Acronym
SHE
Official Title
Identification of New Markers in the Hypereosinophilic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 29, 2010 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose is to characterize new hypereosinophilic syndrome biomarkers more informative and more accessible compared to those that we have already thanks to a proteomic approach. This will help the investigators to diagnose the this disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypereosinophilic Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypereosinophilic syndrome unexplained
Arm Type
Experimental
Arm Title
Hypereosinophilic syndrome explained
Arm Type
Active Comparator
Arm Title
Normal rate of eosinophilic
Arm Type
Sham Comparator
Intervention Type
Biological
Intervention Name(s)
biologie sample
Intervention Description
comparison of biomarkers between HES, HE biomarkers data and control arms
Primary Outcome Measure Information:
Title
The aim is to characterize, through an approach immunoprotéomique, new HES biomarkers more informative and easier access than those currently available to us. These biomarkers will help to the diagnosis of HES, compared with other causes of eosinophilia.
Time Frame
one month after patient inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
dated and signed informed consent
virale serology negative or negative result less than 6 months
virale serology negative for HBV or vaccinated patient
insured
virale serology negative or negative result less than 6 months
negative pregnancy test or female menopause for at least 1 year
Exclusion Criteria:
subject enable adult, under guardianship or under protective measures of justice
Refusal or inability to give informed consent
The hypereosinophilic syndrome explained origin other than than atopy, bullous pemphigoid, the Churg-Strauss syndrome and DRESS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lionel Prin, MD PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU, Hôpital Claude Huriez
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Identification of New Markers in the Hypereosinophilic Syndrome
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