SHE: Identification of New Markers in the Hypereosinophilic Syndrome

• Sponsor: University Hospital, Lille (Other)
• Overall Status: Completed
• CT.gov ID: NCT01713504
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 3
• Actual Duration (Months): 60.1
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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	Phase
Hypereosinophilic Syndrome	Biological: biologie sample	N/A

Study Design

• Study Type: Interventional
• 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: Jun 29, 2010
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

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

Outcome Measures

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. [one month after patient inclusion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	CHRU, Hôpital Claude Huriez	Lille	Nord	France	59037

Sponsors and Collaborators

• University Hospital, Lille

Investigators

• Principal Investigator: Lionel Prin, MD PhD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT01713504
• Other Study ID Numbers: 2008_29; 2009-A00314-53
• First Posted: Oct 24, 2012
• Last Update Posted: Feb 15, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• 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: Hypereosinophilic Syndrome; Syndrome

Study Results

No Results Posted as of Feb 15, 2019