Identification of New Markers in the Hypereosinophilic Syndrome (SHE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by University Hospital, Lille.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Syndrome
Hypereosinophilic Syndrome
Disease
Pathologic Processes
Eosinophilia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014