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Identification of New Markers in the Hypereosinophilic Syndrome (SHE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01713504
First received: October 22, 2012
Last updated: May 17, 2017
Last verified: May 2017
  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: None (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 ]

Enrollment: 41
Actual Study Start Date: June 29, 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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   (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
  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

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
  More Information

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 )
Study First Received: October 22, 2012
Last Updated: May 17, 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

ClinicalTrials.gov processed this record on August 18, 2017