Systemic SclerosisREUSSI-SScNCT04001556
RElevance of UltraSonography for Assessing Salivary Gland Involvement in Systemic Sclerosis (SSc)
A study testing Minor Salivary gland Biopsy, ARFI and MSG US in people with Systemic Sclerosis, run by Rennes University Hospital at 3 sites in France.
Trial summary
As fibrosis of salivary glands is supposed to be the main mechanism involved in Systemic sclerosis (SSc)-associated sicca syndrome, Ultrasonography , biopsy and measuring gland elasticity (by ARFI (Acoustic Radiation Force Impulse)) in SSc patients could also constitute a relevant method to assess the potential… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Minor Salivary gland Biopsy, ARFI and MSG US
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesFrance
- Study dates
- 2 Dec 2019to 4 Mar 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over eighteen years old;
- Fulfilling 2013 ACR classification criteria for Systemic sclerosis (Van den Hoogen et al. 2013);
- 60 patients with subjective sicca symptoms reported by a standardised questionnaire (Vitali C et al. 2002);
- 15 patients without sicca symptoms;
- Who has signed an informed consent
- Benefiting from a social security scheme
Who cannot join
- Treatment: current (or in the past 6 months) immunosuppressive treatment by rituximab or cyclophosphamide (representing less than 5% of SSc patients in the investigator's centres);
- Current (or in the past 6 months) treatment with drugs with anti-cholinergic properties (Selective Serotonin Reuptake Inhibitors and anti-histaminic inhibitors (hydroxyzine));
- Current treatment with antiplatelet aggregates
- Anti-vitamin K treatment (increasing risk of bleeding during minor salivary gland biopsy); and oral anti-coagulant
- Known abnormal coagulation (prolonged aPPT(activated partial thromboplastin time) and / or PT (Prothrombin time ( <70%)), or known thrombocytopenia (<150,000 platelets / mm3)
- Known secondary sicca symptoms : history of head-and-neck radiotherapy, hepatitis C infection, AIDS, sarcoidosis, amyloidosis, graft-vs-host disease and IgG4(Isotype's immunoGlobulin G4)-related disease;
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- Pregnancy or breastfeeding mothers;
- Known intolerance/allergy to xylocain injection;
- Adults legally protected (under judicial protection, guardianship, or supervision), inability to consent.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Brest Service de Rhumatologie
Brest, 29000
CHU rennes
Rennes, 35000
CHU Tours, Service de médecine interne
Tours, 37000
About this study
As fibrosis of salivary glands is supposed to be the main mechanism involved in Systemic sclerosis (SSc)-associated sicca syndrome, Ultrasonography , biopsy and measuring gland elasticity (by ARFI (Acoustic Radiation Force Impulse)) in SSc patients could also constitute a relevant method to assess the potential alterations of echostructure of major salivary glands and the fibrosis of Salivary Glands in this disease.
Read the detailed description
Systemic sclerosis (SSc) is a rare autoimmune chronic disorder characterised by vascular hyper-reactivity and fibrosis of the skin as well as internal organs. Intimal hyperplasia, endothelial dysfunction and occlusive vasculopathy are the underlying basis of these chronic vascular damages. The expression of the vasculopathy especially includes Raynaud phenomenon (RP), digital ulcers (DUs), gastro-intestinal involvement and pulmonary arterial hypertension (PAH). Sicca syndrome is clinically characterised by dryness of the eyes (xerophthalmia) and mouth (xerostomia). The prevalence of sicca symptoms is up to 70% in prospective series of SSc patients. Sicca syndrome is supposed to be primarily related to glandular fibrosis. The prevalence of primary Sjögren Syndrome (pSS) among SSc patients, as defined by the American-European Consensus Group criteria is around 15%. Sicca syndrome is therefore a frequent feature in SSc and constitutes an important cause of quality of life's impairment in SSc If studies have already evaluated clinical and histological alterations of minor salivary glands secondary to sicca syndrome in SSc , only few studies used the recent ACR(American College of Rheumatology) 2013 classification criteria for SSc to select patients. SGUS(Salivary Gland UltraSonography) evaluation in SSc has never been assessed to date. Potential alterations of MSG (Major Salivary Gland) echostructure in SSc have never been described to date. The performances and reliability of SGUS to assessed MSG involvement in SSc are still to be determined. As fibrosis of salivary glands is supposed to be the main mechanism involved in SSc-associated sicca syndrome, measuring salivary-gland elasticity using ARFI-ultrasonography in SSc patients could also constitute a relevant method to assess the fibrosis of MSG in this disease. A cross-sectional pilot study is therefore needed to explore these relevant questions about sicca syndrome in SSc.
- Conditions
- Systemic Sclerosis
- Being tested
- Minor Salivary gland Biopsy, ARFI, MSG US
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minor Salivary gland BiopsyDiagnostic test
Minor salivary gland biopsy with injection of lidocain
ARFIDiagnostic test
Acoustic Radiation Force Impulse on Major Salivary Glands
MSG USDiagnostic test
Ultrasonography of Major Salivary Glands
| Study group | Role | What they receive |
|---|---|---|
| Patients reporting subjective sicca symptoms | Experimental | HAQ(Health Assessment Questionnaire) Score, bilateral schirmer 's test, unstimulated whole salivary flow rate, blood sample for immunologic evaluation Receives: Diagnostic Test: Minor Salivary gland Biopsy; Diagnostic Test: ARFI; Diagnostic Test: MSG US |
| Patients without subjective sicca symptoms | Experimental | HAQ(Health Assessment Questionnaire) score, bilateral schirmer 's test, unstimulated whole salivary flow rate, blood sample for immunologic evaluation Receives: Diagnostic Test: ARFI; Diagnostic Test: MSG US |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography characteristics of major salivary glands
Ultrasonography characteristics of major salivary glands based on Salaffi's composite score.
each MSG will be scored as followed:
- grade 0 = normal homogeneous glands;
- grade 1 = Homogenous borders, slightly heterogeneous parenchyma,
- grade 2 = Homogenous borders, multiple hypoechogenic areas measuring < 2 mm,
- grade 3 = multiple hypoechogenic areas measuring 2-6 mm or irregular borders or invisible posterior part of the gland;
- grade 4 = unstructured glandular parenchyma with multiple hypoechogenic areas measuring >6 mm or calcifications with echogenic bands.
In each patient, 4 grades can be obtained (1 grade per gland);
the sum of these 4 grades (range 0-16) will be the Salaffi's score.
A score of 0 has the best outcome, of 16 the worse
Measured: up to six months (at evaluation visit)
Ultrasonography characteristics of major salivary glands
Ultrasonography characteristics of major salivary glands based on bilateral ARFI(Acoustic radiation force Impulse) elastometry
Measured: up to six months (at evaluation visit)
Secondary outcomes (12)
Variants of the Salaffi score
Scores of Hocevar,based on the same ultrasound parameters but with a weighting different from that of Salaffi in the calculation of the score.
Echostructure of the four salivary glands will be graded 0 to 12 ; the sum of these 4 grades (range 0-48) will be the Hocevar's score. A score of 0 has the best outcome, of 48 the worse.
Measured: up to six months (evaluation visit)
Variants of the Salaffi score
Scores of Milic,based on the same ultrasound parameters but with a weighting different from that of Salaffi in the calculation of the score.
Echostructure of the four salivary glands will be graded 0 to 3 ; the sum of these 4 grades (range 0-12) will be the Milic's score. A score of 0 has the best outcome, of 12 the worse.
Measured: up to six months (evaluation visit)
Variants of the Salaffi score
Scores Jousse-Joulin / Cornec constituting , based on the same ultrasound parameters but with a weighting different from that of Salaffi in the calculation of the score.
Echostructure of the four salivary glands will be graded 0 to 4 ; the sum of these 4 grades (range 0-16) will be the Jousse-Joulin/Cornec's score.
A score of 0 has the best outcome, of 16 the worse.
Measured: up to six months (evaluation visit)
Biopsy of the minor salivary glands
Biopsies of the minor salivary glands with standardized histological characterization of the Chisholm score.
Chisholm'score will evaluate the number of lymphocytic foci/4mm2 grade 1 : none or slight, grade 2 : less than 50 lymphocytes and histocytes, grade 3 : one focus with at least 50 lymphocytes, grade 4 : More than one focus with at least 50 lymphocytes,
Grade 1 has the best outcome, grade 4 the worse.
Measured: up to six months (evaluation visit)
Biopsy of the minor salivary glands
Biopsies of the minor salivary glands with standardized characterization of the focus score.
Focus score : the number of mononuclear cell infiltrates containing at least 50 inflammatory cells in a 4 mm2 glandular section,
Focus score 0 = no mononuclear cell infiltrate containing at least 50 inflammatory cells in a 4 mm2 glandular section,
Focus score =1 or >1 : one or more mononuclear cell infiltrates containing at least 50 inflammatory cells in a 4 mm2 glandular section,
Focus score 0 has the best outcome Focus score =1 or >1 has the worse outcome
Measured: up to six months (evaluation visit)
Biopsy of the minor salivary glands
Biopsies of the minor salivary glands with evaluation of fibrosis assessed from F1 to F4
Measured: up to six months (evaluation visit)
Evaluation of the presence or absence of objective criteria of Sjogren
Evaluation of the presence or absence of objective criteria of Sjogren according to salivary flow test
Measured: up to six months (evaluation visit)
Evaluation of the presence or absence of objective criteria of Sjogren
Evaluation of the presence or absence of objective criteria of Sjogren according to Schirmer test.
Measured: up to six months (evaluation visit)
Clinical evaluation of systemic scleroderma lesions
forms of the disease
Measured: up to six months (evaluation visit)
Clinical evaluation of systemic scleroderma lesions
duration of evolution of the disease
Measured: up to six months (evaluation visit)
Clinical evaluation of systemic scleroderma lesions
visceral damage : Presence or absence of pulmonary involvement on CT scan, Presence or absence of pulmonary arterial hypertension on echocardiography.
Measured: up to six months (evaluation visit)
Clinical evaluation of systemic scleroderma lesions
immunological data : Positivity of : Anti SSA(Anti Sjögren Syndrom A) antibodies,Anti SSb(Anti Sjögren syndrom B) antibodies,Anti Topoisomerase antibodies, Anti Centromere antibodies, Anti RNA polymerase III antibodies
Using Indirect ImmunoFluorescence (IFI) ( as binary parameter (positive or negative)
Measured: up to six months (evaluation visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start2 Dec 2019
- Primary completion4 Mar 2022
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- cross-sectionnal pilot study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick JEGO, MD, Principal investigator, University Hospital of Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001556
- Sponsor's protocol ID
- 35RC18_9905
- Acronym
- REUSSI-SSc
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2019
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Salaffi F, Argalia G, Carotti M, Giannini FB, Palombi C. Salivary gland ultrasonography in the evaluation of primary Sjogren's syndrome. Comparison with minor salivary gland biopsy. J Rheumatol. 2000 May;27(5):1229-36.
PubMed 10813292Hocevar A, Ambrozic A, Rozman B, Kveder T, Tomsic M. Ultrasonographic changes of major salivary glands in primary Sjogren's syndrome. Diagnostic value of a novel scoring system. Rheumatology (Oxford). 2005 Jun;44(6):768-72. doi: 10.1093/rheumatology/keh588. Epub 2005 Mar 1.
PubMed 15741192Milic VD, Petrovic RR, Boricic IV, Radunovic GL, Pejnovic NN, Soldatovic I, Damjanov NS. Major salivary gland sonography in Sjogren's syndrome: diagnostic value of a novel ultrasonography score (0-12) for parenchymal inhomogeneity. Scand J Rheumatol. 2010 Mar;39(2):160-6. doi: 10.3109/03009740903270623.
PubMed 20059370Jousse-Joulin S, Milic V, Jonsson MV, Plagou A, Theander E, Luciano N, Rachele P, Baldini C, Bootsma H, Vissink A, Hocevar A, De Vita S, Tzioufas AG, Alavi Z, Bowman SJ, Devauchelle-Pensec V; US-pSS Study Group. Is salivary gland ultrasonography a useful tool in Sjogren's syndrome? A systematic review. Rheumatology (Oxford). 2016 May;55(5):789-800. doi: 10.1093/rheumatology/kev385. Epub 2015 Dec 14.
PubMed 26667216Cornec D, Jousse-Joulin S, Pers JO, Marhadour T, Cochener B, Boisrame-Gastrin S, Nowak E, Youinou P, Saraux A, Devauchelle-Pensec V. Contribution of salivary gland ultrasonography to the diagnosis of Sjogren's syndrome: toward new diagnostic criteria? Arthritis Rheum. 2013 Jan;65(1):216-25. doi: 10.1002/art.37698.
PubMed 23108632
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RElevance of UltraSonography for Assessing Salivary Gland Involvement in Systemic Sclerosis (SSc)
- ClinicalTrials.gov ID
- NCT04001556
- Acronym / sponsor ID
- REUSSI-SSc / 35RC18_9905
- Conditions
- Systemic Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 28 Jun 2019 (actual)
- 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.
As fibrosis of salivary glands is supposed to be the main mechanism involved in Systemic sclerosis (SSc)-associated sicca syndrome, Ultrasonography , biopsy and measuring gland elasticity (by ARFI (Acoustic Radiation Force Impulse)) in SSc patients could also constitute a relevant method to assess the potential alterations of echostructure of major salivary glands and the fibrosis of Salivary Glands in this disease.
Detailed description
Systemic sclerosis (SSc) is a rare autoimmune chronic disorder characterised by vascular hyper-reactivity and fibrosis of the skin as well as internal organs. Intimal hyperplasia, endothelial dysfunction and occlusive vasculopathy are the underlying basis of these chronic vascular damages. The expression of the vasculopathy especially includes Raynaud phenomenon (RP), digital ulcers (DUs), gastro-intestinal involvement and pulmonary arterial hypertension (PAH). Sicca syndrome is clinically characterised by dryness of the eyes (xerophthalmia) and mouth (xerostomia). The prevalence of sicca symptoms is up to 70% in prospective series of SSc patients. Sicca syndrome is supposed to be primarily related to glandular fibrosis. The prevalence of primary Sjögren Syndrome (pSS) among SSc patients, as defined by the American-European Consensus Group criteria is around 15%. Sicca syndrome is therefore a frequent feature in SSc and constitutes an important cause of quality of life's impairment in SSc If studies have already evaluated clinical and histological alterations of minor salivary glands secondary to sicca syndrome in SSc , only few studies used the recent ACR(American College of Rheumatology) 2013 classification criteria for SSc to select patients. SGUS(Salivary Gland UltraSonography) evaluation in SSc has never been assessed to date. Potential alterations of MSG (Major Salivary Gland) echostructure in SSc have never been described to date. The performances and reliability of SGUS to assessed MSG involvement in SSc are still to be determined. As fibrosis of salivary glands is supposed to be the main mechanism involved in SSc-associated sicca syndrome, measuring salivary-gland elasticity using ARFI-ultrasonography in SSc patients could also constitute a relevant method to assess the fibrosis of MSG in this disease. A cross-sectional pilot study is therefore needed to explore these relevant questions about sicca syndrome in SSc.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- cross-sectionnal pilot study
| Arm | Type | Receives |
|---|---|---|
| Patients reporting subjective sicca symptoms | Experimental | Diagnostic Test: Minor Salivary gland Biopsy, Diagnostic Test: ARFI, Diagnostic Test: MSG USHAQ(Health Assessment Questionnaire) Score, bilateral schirmer 's test, unstimulated whole salivary flow rate, blood sample for immunologic evaluation |
| Patients without subjective sicca symptoms | Experimental | Diagnostic Test: ARFI, Diagnostic Test: MSG USHAQ(Health Assessment Questionnaire) score, bilateral schirmer 's test, unstimulated whole salivary flow rate, blood sample for immunologic evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients over eighteen years old;
- Fulfilling 2013 ACR classification criteria for Systemic sclerosis (Van den Hoogen et al. 2013);
- 60 patients with subjective sicca symptoms reported by a standardised questionnaire (Vitali C et al. 2002);
- 15 patients without sicca symptoms;
- Who has signed an informed consent
Key exclusion criteria (9 listed)
- Treatment: current (or in the past 6 months) immunosuppressive treatment by rituximab or cyclophosphamide (representing less than 5% of SSc patients in the investigator's centres);
- Current (or in the past 6 months) treatment with drugs with anti-cholinergic properties (Selective Serotonin Reuptake Inhibitors and anti-histaminic inhibitors (hydroxyzine));
- Current treatment with antiplatelet aggregates
- Anti-vitamin K treatment (increasing risk of bleeding during minor salivary gland biopsy); and oral anti-coagulant
- Known abnormal coagulation (prolonged aPPT(activated partial thromboplastin time) and / or PT (Prothrombin time ( <70%)), or known thrombocytopenia (<150,000 platelets / mm3)
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 |
|---|---|---|
| Minor Salivary gland BiopsyMinor salivary gland biopsy with injection of lidocain | Diagnostic test | Patients reporting subjective sicca symptoms |
| ARFIAcoustic Radiation Force Impulse on Major Salivary Glands | Diagnostic test | Patients reporting subjective sicca symptoms, Patients without subjective sicca symptoms |
| MSG USUltrasonography of Major Salivary Glands | Diagnostic test | Patients reporting subjective sicca symptoms, Patients without subjective sicca symptoms |
Primary outcome
Ultrasonography characteristics of major salivary glands
Time frame: up to six months (at evaluation visit)
Ultrasonography characteristics of major salivary glands based on Salaffi's composite score. each MSG will be scored as followed: * grade 0 = normal homogeneous glands; * grade 1 = Homogenous borders, slightly heterogeneous parenchyma, * grade 2 = Homogenous borders, multiple hypoechogenic areas measuring < 2 mm, * grade 3 = multiple hypoechogenic areas measuring 2-6 mm or irregular borders or invisible posterior part of the gland; * grade 4 = unstructured glandular parenchyma with multiple hypoechogenic areas measuring >6 mm or calcifications with echogenic bands. In each patient, 4 grades can be obtained (1 grade per gland); the sum of these 4 grades (range 0-16) will be the Salaffi's score. A score of 0 has the best outcome, of 16 the worse
Ultrasonography characteristics of major salivary glands
Time frame: up to six months (at evaluation visit)
Ultrasonography characteristics of major salivary glands based on bilateral ARFI(Acoustic radiation force Impulse) elastometry
12 secondary outcomes
Variants of the Salaffi score
Time frame: up to six months (evaluation visit)
Variants of the Salaffi score
Time frame: up to six months (evaluation visit)
Variants of the Salaffi score
Time frame: up to six months (evaluation visit)
Biopsy of the minor salivary glands
Time frame: up to six months (evaluation visit)
Biopsy of the minor salivary glands
Time frame: up to six months (evaluation visit)
Biopsy of the minor salivary glands
Time frame: up to six months (evaluation visit)
Evaluation of the presence or absence of objective criteria of Sjogren
Time frame: up to six months (evaluation visit)
Evaluation of the presence or absence of objective criteria of Sjogren
Time frame: up to six months (evaluation visit)
Clinical evaluation of systemic scleroderma lesions
Time frame: up to six months (evaluation visit)
Clinical evaluation of systemic scleroderma lesions
Time frame: up to six months (evaluation visit)
Clinical evaluation of systemic scleroderma lesions
Time frame: up to six months (evaluation visit)
Clinical evaluation of systemic scleroderma lesions
Time frame: up to six months (evaluation visit)
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 5 Apr 2022.
- Background: PubMed 10813292Salaffi F, Argalia G, Carotti M, Giannini FB, Palombi C. Salivary gland ultrasonography in the evaluation of primary Sjogren's syndrome. Comparison with minor salivary gland biopsy. J Rheumatol. 2000 May;27(5):1229-36.
- Background: PubMed 15741192Hocevar A, Ambrozic A, Rozman B, Kveder T, Tomsic M. Ultrasonographic changes of major salivary glands in primary Sjogren's syndrome. Diagnostic value of a novel scoring system. Rheumatology (Oxford). 2005 Jun;44(6):768-72. doi: 10.1093/rheumatology/keh588. Epub 2005 Mar 1.
- Background: PubMed 20059370Milic VD, Petrovic RR, Boricic IV, Radunovic GL, Pejnovic NN, Soldatovic I, Damjanov NS. Major salivary gland sonography in Sjogren's syndrome: diagnostic value of a novel ultrasonography score (0-12) for parenchymal inhomogeneity. Scand J Rheumatol. 2010 Mar;39(2):160-6. doi: 10.3109/03009740903270623.
- Background: PubMed 26667216Jousse-Joulin S, Milic V, Jonsson MV, Plagou A, Theander E, Luciano N, Rachele P, Baldini C, Bootsma H, Vissink A, Hocevar A, De Vita S, Tzioufas AG, Alavi Z, Bowman SJ, Devauchelle-Pensec V; US-pSS Study Group. Is salivary gland ultrasonography a useful tool in Sjogren's syndrome? A systematic review. Rheumatology (Oxford). 2016 May;55(5):789-800. doi: 10.1093/rheumatology/kev385. Epub 2015 Dec 14.
- Background: PubMed 23108632Cornec D, Jousse-Joulin S, Pers JO, Marhadour T, Cochener B, Boisrame-Gastrin S, Nowak E, Youinou P, Saraux A, Devauchelle-Pensec V. Contribution of salivary gland ultrasonography to the diagnosis of Sjogren's syndrome: toward new diagnostic criteria? Arthritis Rheum. 2013 Jan;65(1):216-25. doi: 10.1002/art.37698.
- Individual participant dataSharing planned: Undecided
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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.
Patrick JEGO, MD principal investigator
University Hospital of Rennes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minor Salivary gland Biopsy, ARFI and MSG US in people with Systemic Sclerosis, run by Rennes University Hospital at 3 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 6 inclusion and 9 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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Ultrasonography characteristics of major salivary glands (time frame: up to six months (at evaluation visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04001556, which also lists 5 linked publications.
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 5 Apr 2022.