Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT01713504
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2012-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identification of New Markers in the Hypereosinophilic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017681', 'term': 'Hypereosinophilic Syndrome'}], 'ancestors': [{'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2012-10-22', 'studyFirstSubmitQcDate': '2012-10-23', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'one month after patient inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypereosinophilic Syndrome']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* dated and signed informed consent\n* virale serology negative or negative result less than 6 months\n* virale serology negative for HBV or vaccinated patient\n* insured\n* virale serology negative or negative result less than 6 months\n* negative pregnancy test or female menopause for at least 1 year\n\nExclusion Criteria:\n\n* subject enable adult, under guardianship or under protective measures of justice\n* Refusal or inability to give informed consent\n* The hypereosinophilic syndrome explained origin other than than atopy, bullous pemphigoid, the Churg-Strauss syndrome and DRESS'}, 'identificationModule': {'nctId': 'NCT01713504', 'acronym': 'SHE', 'briefTitle': 'Identification of New Markers in the Hypereosinophilic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Identification of New Markers in the Hypereosinophilic Syndrome', 'orgStudyIdInfo': {'id': '2008_29'}, 'secondaryIdInfos': [{'id': '2009-A00314-53', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypereosinophilic syndrome unexplained', 'interventionNames': ['Biological: biologie sample']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hypereosinophilic syndrome explained', 'interventionNames': ['Biological: biologie sample']}, {'type': 'SHAM_COMPARATOR', 'label': 'Normal rate of eosinophilic', 'interventionNames': ['Biological: biologie sample']}], 'interventions': [{'name': 'biologie sample', 'type': 'BIOLOGICAL', 'description': 'comparison of biomarkers between HES, HE biomarkers data and control arms', 'armGroupLabels': ['Hypereosinophilic syndrome explained', 'Hypereosinophilic syndrome unexplained', 'Normal rate of eosinophilic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'CHRU, Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Lionel Prin, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}