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Identification of New Markers in the Hypereosinophilic Syndrome (SHE)

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ClinicalTrials.gov Identifier: NCT01713504
Recruitment Status : Active, not recruiting
First Posted : October 24, 2012
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease Intervention/treatment
Hypereosinophilic Syndrome Biological: biologie sample

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Identification of New Markers in the Hypereosinophilic Syndrome
Actual Study Start Date : June 29, 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Hypereosinophilic syndrome unexplained Biological: biologie sample
comparison of biomarkers between HES, HE biomarkers data and control arms
Active Comparator: Hypereosinophilic syndrome explained Biological: biologie sample
comparison of biomarkers between HES, HE biomarkers data and control arms
Sham Comparator: Normal rate of eosinophilic Biological: biologie sample
comparison of biomarkers between HES, HE biomarkers data and control arms



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713504


Locations
France
CHRU, Hôpital Claude Huriez
Lille, Nord, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Lionel Prin, MD PhD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01713504     History of Changes
Other Study ID Numbers: 2008_29
2009-A00314-53 ( Other Identifier: ID-RCB number, ANSM )
First Posted: October 24, 2012    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Hypereosinophilic Syndrome
Disease
Pathologic Processes
Eosinophilia
Leukocyte Disorders
Hematologic Diseases