Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2010-03-31
2012-08-31
Brief Summary
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The aim of the study is to compare Sjögren's syndrome systemic activity to seric, lymphocytic and conjunctival levels of NTs (i.e NGF, BDNF and NT-3). A preliminary study has previously pointed out the link between high BDNF seric levels and Sjögren's systemic activity. The increased levels of BDNF were correlated to T cell activation. A similar correlation between high NGF level and hypergammaglobulinemia was also pointed out.
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Detailed Description
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Salivary sicca syndrome will be evaluated with un-stimulated salivary flow rate. Saliva fluid will be collected from NTs levels determination (ELISA). Ocular sicca syndrome will be evaluated by Schirmer tests and Lissaline green test. A conjunctival cytological impression will be done in order to determine NTs conjunctival production by flow cytometry.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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primary Sjögren syndrome
blood sample
blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up
Healthy volunteers
blood sample
blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up
Interventions
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blood sample
blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All patients must fulfill the revised criteria for primary Sjögren syndrome.
* Age of entry into the study ≥ 18 yrs.
* Affiliated or profit patient of a social security system.
* Informed consent signed up.
Arm : healthy volunteers:
* All patient free of autoimmune disease.
* Age of entry into the study ≥ 18 yrs.
* Affiliated or profit patient of a social security system.
* Informed consent signed up.
Exclusion Criteria
* Addictive behaviors (alcoholism, cocaine or opioid abuse).
* Patient with anti-depressive drugs.
* Patient with concurrent malignancy
* Pregnancy
* Patients under measure of maintenance of justice.
* Patients unable to understand or to participate to the study.
* Child and major patients making the object of a measure of lawful protection.
* Patients deprived of freedom.
* Autoimmune disease.
* Steroid treatment (\>20 mg/day).
* Immunosuppressive treatment.
* Concurrent malignancy.
* Concurrent psychiatric disorders.
* Anti-depressive drugs.
* Pregnancy.
18 Years
ALL
Yes
Sponsors
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University Hospital, Limoges
OTHER
Responsible Party
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Principal Investigators
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Anne-Laure FAUCHAIS, MD
Role: PRINCIPAL_INVESTIGATOR
Limoges UH
Locations
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Médecine Interne
Limoges, , France
Opthalmologie
Limoges, , France
Countries
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Other Identifiers
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I08010
Identifier Type: -
Identifier Source: org_study_id
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