Identification of New Markers in the Hypereosinophilic Syndrome (SHE)

This study is currently recruiting participants.

Verified June 2009 by University Hospital, Lille

Sponsor:

Information provided by (Responsible Party):

University Hospital, Lille

ClinicalTrials.gov Identifier:

NCT01713504

First received: October 22, 2012

Last updated: October 23, 2012

Last verified: June 2009

History of Changes

Purpose

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	Intervention
Hypereosinophilic Syndrome	Biological: biologie sample

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Identification of New Markers in the Hypereosinophilic Syndrome

Resource links provided by NLM:

Genetics Home Reference related topics: PDGFRA-associated chronic eosinophilic leukemia PDGFRB-associated chronic eosinophilic leukemia

U.S. FDA Resources

Further study details as provided by University Hospital, Lille:

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. [ Time Frame: one month after patient inclusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	June 2010
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713504

Contacts

Contact: Lionel Prin, MD PhD

(33)320 445 574

l-prin@chru-lille.fr

Locations

France
University hospital	Recruiting
Lille, Nord, France, 59037
Contact: Lionel Prin, MD PhD (33)320 445 574 l-prin@hru-lille.fr
Sub-Investigator: Pierre-Yves Hatron, MD PhD

Sponsors and Collaborators

University Hospital, Lille

Investigators

Principal Investigator:

Lionel Prin, MD PhD

University Hospital, Lille

More Information

No publications provided

Responsible Party:	University Hospital, Lille
ClinicalTrials.gov Identifier:	NCT01713504 History of Changes
Other Study ID Numbers:	CHRU of Lille
Study First Received:	October 22, 2012
Last Updated:	October 23, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:

Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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