Primary Sjögren SyndromeNeuro-SGSpNCT01081184
Neurotrophins Implications in Primary Sjögren Syndrome
An observational study of Primary Sjögren Syndrome, run by University Hospital, Limoges at 2 sites in France.
Trial summary
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 "… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Sjögren Syndrome
- What is being tested?
- blood sample
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2010to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with primary Sjögren syndrome People free of disease : healthy volunteers
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the detailed description
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
- Primary Sjögren Syndrome
- Being tested
- blood sample
- Keywords
- primary Sjögren syndrome, neurotrophins, B cell, sicca syndrome, T cell
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
Also called Salivary sicca syndrome will be evaluated., Saliva fluid will be collected., Ocular sicca syndrome will be evaluated., A conjonctival cytological impression will be done.
blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up
| Study group | Role | What they receive |
|---|---|---|
| primary Sjögren syndrome | Not described Receives: Biological: blood sample | |
| Healthy volunteers | Not described Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphocytic levels of NTs (i.e. NGF, BDNF and NT-3)
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.
Measured: 1 day
Secondary outcomes (1)
Disease activity score used: ESSDAI; NGF, BDNF and NT3 levels in sera; pSS immunological profile; intensity of sicca syndrome; salivary levels of NTs; conjunctival expression of NTs.
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 conjonctival production by flow cytometry.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Laure FAUCHAIS, MD, Principal investigator, Limoges UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081184
- Sponsor's protocol ID
- I08010
- Acronym
- Neuro-SGSp
- Status last verified
- Mar 2010
- First submitted
- 3 Mar 2010
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurotrophins Implications in Primary Sjögren Syndrome
- ClinicalTrials.gov ID
- NCT01081184
- Acronym / sponsor ID
- Neuro-SGSp / I08010
- Conditions
- Primary Sjögren Syndrome
- Keywords
- primary Sjögren syndrome, neurotrophins, B cell, sicca syndrome, T cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary Sjögren syndrome | – | Biological: blood sample |
| Healthy volunteers | – | Biological: blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with primary Sjögren syndrome People free of disease : healthy volunteers
Key inclusion criteria (10 listed)
- 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.
- All patient free of autoimmune disease.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleAlso: Salivary sicca syndrome will be evaluated., Saliva fluid will be collected., Ocular sicca syndrome will be evaluated., A conjonctival cytological impression will be done.blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up | Biological | Healthy volunteers, primary Sjögren syndrome |
Primary outcome
Lymphocytic levels of NTs (i.e. NGF, BDNF and NT-3)
Time frame: 1 day
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.
1 secondary outcome
Disease activity score used: ESSDAI; NGF, BDNF and NT3 levels in sera; pSS immunological profile; intensity of sicca syndrome; salivary levels of NTs; conjunctival expression of NTs.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Laure FAUCHAIS, MD principal investigator
Limoges UH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Sjögren Syndrome, run by University Hospital, Limoges at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphocytic levels of NTs (i.e. NGF, BDNF and NT-3) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2013.