Neurotrophins Implications in Primary Sjögren Syndrome

NCT ID: NCT01081184

Last Updated: 2013-04-17

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-08-31

Brief Summary

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Neurotrophins (NTs) constitute a family of growth factors, which regulated differentiation, proliferation, and survival of both neuronal cells and astrocytes. In recent years, several studies have provided evidences that the cellular effects of NGF " Nerve Growth Factor ", BDNF " Brain-Derived Neurotrophic Factor " and NT-3 are not limited to the nervous system. Indeed, neurotrophins and their receptors are widely expressed on non neuronal cells. Data concerning the implication of NTs and their receptors in the immune system maturation and in the regulation of normal and pathological immune responses are numerous and suggest the existence of a specific "neuro-immunomodulation" through these neuropeptides.

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.

Detailed Description

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2 supplementary blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up.

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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Primary Sjögren Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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primary Sjögren syndrome

blood sample

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Salivary sicca syndrome will be evaluated. Saliva fluid will be collected. Ocular sicca syndrome will be evaluated. A conjonctival cytological impression will be done.

Eligibility Criteria

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Inclusion Criteria

Arm : primary Sjögren syndrome:

* 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

* Patient with psychiatric disorders not related with antiphospholipid syndrome and / or cerebral complication of SGSp.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Laure FAUCHAIS, MD

Role: PRINCIPAL_INVESTIGATOR

Limoges UH

Locations

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Médecine Interne

Limoges, , France

Site Status

Opthalmologie

Limoges, , France

Site Status

Countries

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France

Other Identifiers

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I08010

Identifier Type: -

Identifier Source: org_study_id

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