- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01713504
Identification of New Markers in the Hypereosinophilic Syndrome (SHE)
January 6, 2026 updated by: University Hospital, Lille
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nord
-
Lille, Nord, France, 59037
- CHRU, Hôpital Claude Huriez
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hypereosinophilic syndrome unexplained
|
comparison of biomarkers between HES, HE biomarkers data and control arms
|
|
Active Comparator: Hypereosinophilic syndrome explained
|
comparison of biomarkers between HES, HE biomarkers data and control arms
|
|
Sham Comparator: Normal rate of eosinophilic
|
comparison of biomarkers between HES, HE biomarkers data and control arms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
one month after patient inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lionel Prin, MD PhD, University Hospital, Lille
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2010
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
October 22, 2012
First Submitted That Met QC Criteria
October 23, 2012
First Posted (Estimated)
October 24, 2012
Study Record Updates
Last Update Posted (Estimated)
January 8, 2026
Last Update Submitted That Met QC Criteria
January 6, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008_29
- 2009-A00314-53 (Other Identifier: ID-RCB number, ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.