Systemic SclerosisNCT03143413
Echo Systemic Sclerosis
An observational study of Systemic Sclerosis and Gougerot Sjogren Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Systemic sclerosis is an autoimmune connective tissue disease with undefined etiology and characterized by progressive fibrosis of the skin and major organs. Dry eyes and / or buccal syndrome is commonly reported in patients with systemic sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Gougerot Sjogren Syndrome, Sicca-Asthenia-Polyalgia Syndrome
- What is being tested?
- Ultrasonography
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2017to May 2019
- 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
- Adult, Older adult
Study population: 20 systemic sclerosis, 40 Gougerot-Sjogren syndrome, 40 Sicca-Asthenia-Polyalgia
Who may be able to join
- Systemic sclerosis diagnosis established by a rheumatologist and met ACR 2012 criteria
- Or primary Gougerot-Sjogren patient who met American-European Consensus Group (AECG) classification criteria.
- Or patient presenting a sicca syndrome but not met Gougerot-Sjogren criteria
Who cannot join
- History of radiotherapy on face and neck
- Infection such as VIH or Hepatitis C
- Sarcoidosis
- Amylosis
- Wearing contact lenses
- Hyper IgG4 syndrome
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Marion COUDERC, MD, 04 73 75 14 88, mcouderc@chu-clermontferrand.fr
About this study
Official title: Ultrasonography Features of the Salivary Glands in Patient With Systemic Sclerosis: Comparison With Gougerot-Sjogren Syndrome and Sicca Asthenia Polyalgia Syndrome
Systemic sclerosis is an autoimmune connective tissue disease with undefined etiology and characterized by progressive fibrosis of the skin and major organs. Dry eyes and / or buccal syndrome is commonly reported in patients with systemic sclerosis. Goujerot-Sjogren syndrome is a chronic autoimmune disorder that is characterized by dryness of the eyes (xerophthalmia) and / or mouth (xerostomia). It may be primary or secondary to another connective tissue disease (such as lupus, rheumatoid arthritis or other). Several criteria have been validated to classify the SS but require a labial salivary gland biopsy, invasive act which complications can sometimes be reported (hematoma, lip sensory defect).
Several scores based on the evaluation of the ultrasound homogeneity of the salivary glands were developed but no studies have evaluated ultrasound abnormalities of salivary glands in patients with systemic sclerosis.
Read the detailed description
Descriptive explorative study of three population showing sicca symptoms (Systemic sclerosis, Gougerot-Sjogren syndrome, Sicca-Asthenia-Polyalgia syndrome).
Patient will be enrolled in the rheumatology department of University hospital of Clermont-Ferrand (France).
Salivary glands ultrasonography will be performed on all patients enrolled by the same expert and blinded to the diagnosis of the patient. Echostructure of the two salivary glands will be graded 0 to 4 and the size calculated.
- Being tested
- Ultrasonography
- Keywords
- Salivary glands ultrasonography, Systemic sclerosis, Gougerot Sjogren syndrome, Sicca syndrome
- Medical subject headings
- Scleroderma, Systemic, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyOther
Patient will be enrolled in the rheumatology department of University hospital of Clermont-Ferrand (France).
Salivary glands ultrasonography will be performed on all patients enrolled by the same expert and blinded to the diagnosis of the patient. Echostructure of the two salivary glands will be graded 0 to 4 and the size calculated.
| Study group | Role | What they receive |
|---|---|---|
| Systemic sclerosis | Systemic sclerosis is an autoimmune connective tissue disease with undefined etiology and characterized by progressive fibrosis of the skin and major organs. Dry eyes and / or buccal syndrome is commonly reported in patients with systemic sclerosis. Receives: Other: Ultrasonography | |
| Gougerot-Sjogren syndrome | Goujerot-Sjogren syndrome is a chronic autoimmune disorder that is characterized by dryness of the eyes (xerophthalmia) and / or mouth (xerostomia). Receives: Other: Ultrasonography | |
| Sicca-Asthenia-Polyalgia syndrome | It may be primary or secondary to another connective tissue disease (such as lupus, rheumatoid arthritis or other). Receives: Other: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jousse-Joulin ultrasonography score
Echostructure of the two salivary glands will be graded 0 to 4 and the size calculated.
Measured: the day of inclusion
Secondary outcomes (4)
Ultrasonography score equal or higher than 2 on at least one salivary gland
Measured: the day of inclusion
Ultrasonography score equal or higher than 3 on at least one salivary gland
Measured: the day of inclusion
Global ultrasonography score higher than 6/16
Measured: the day of inclusion
Salivary glands area
Measured: the day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start24 Mar 2017
- Primary completionMar 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143413
- Sponsor's protocol ID
- CHU-323
- Other IDs
- 2016-A01256-45
- Status last verified
- Apr 2018
- First submitted
- 4 May 2017
- Last updated
- 1 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography Features of the Salivary Glands in Patient With Systemic Sclerosis: Comparison With Gougerot-Sjogren Syndrome and Sicca Asthenia Polyalgia Syndrome
- ClinicalTrials.gov ID
- NCT03143413
- Acronym / sponsor ID
- CHU-323
- Keywords
- Salivary glands ultrasonography, Systemic sclerosis, Gougerot Sjogren syndrome, Sicca syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 8 May 2017 (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.
Systemic sclerosis is an autoimmune connective tissue disease with undefined etiology and characterized by progressive fibrosis of the skin and major organs. Dry eyes and / or buccal syndrome is commonly reported in patients with systemic sclerosis. Goujerot-Sjogren syndrome is a chronic autoimmune disorder that is characterized by dryness of the eyes (xerophthalmia) and / or mouth (xerostomia). It may be primary or secondary to another connective tissue disease (such as lupus, rheumatoid arthritis or other). Several criteria have been validated to classify the SS but require a labial salivary gland biopsy, invasive act which complications can sometimes be reported (hematoma, lip sensory defect).
Several scores based on the evaluation of the ultrasound homogeneity of the salivary glands were developed but no studies have evaluated ultrasound abnormalities of salivary glands in patients with systemic sclerosis.
Detailed description
Descriptive explorative study of three population showing sicca symptoms (Systemic sclerosis, Gougerot-Sjogren syndrome, Sicca-Asthenia-Polyalgia syndrome).
Patient will be enrolled in the rheumatology department of University hospital of Clermont-Ferrand (France).
Salivary glands ultrasonography will be performed on all patients enrolled by the same expert and blinded to the diagnosis of the patient. Echostructure of the two salivary glands will be graded 0 to 4 and the size calculated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Systemic sclerosis | – | Other: UltrasonographySystemic sclerosis is an autoimmune connective tissue disease with undefined etiology and characterized by progressive fibrosis of the skin and major organs. Dry eyes and / or buccal syndrome is commonly reported in patients with systemic sclerosis. |
| Gougerot-Sjogren syndrome | – | Other: UltrasonographyGoujerot-Sjogren syndrome is a chronic autoimmune disorder that is characterized by dryness of the eyes (xerophthalmia) and / or mouth (xerostomia). |
| Sicca-Asthenia-Polyalgia syndrome | – | Other: UltrasonographyIt may be primary or secondary to another connective tissue disease (such as lupus, rheumatoid arthritis or other). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 20 systemic sclerosis, 40 Gougerot-Sjogren syndrome, 40 Sicca-Asthenia-Polyalgia
Key inclusion criteria (3 listed)
- Systemic sclerosis diagnosis established by a rheumatologist and met ACR 2012 criteria
- Or primary Gougerot-Sjogren patient who met American-European Consensus Group (AECG) classification criteria.
- Or patient presenting a sicca syndrome but not met Gougerot-Sjogren criteria
Key exclusion criteria (6 listed)
- History of radiotherapy on face and neck
- Infection such as VIH or Hepatitis C
- Sarcoidosis
- Amylosis
- Wearing contact lenses
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 |
|---|---|---|
| UltrasonographyPatient will be enrolled in the rheumatology department of University hospital of Clermont-Ferrand (France). Salivary glands ultrasonography will be performed on all patients enrolled by the same expert and blinded to the diagnosis of the patient. Echostructure of the two salivary glands will be graded 0 to 4 and the size calculated. | Other | Gougerot-Sjogren syndrome, Sicca-Asthenia-Polyalgia syndrome, Systemic sclerosis |
Primary outcome
Jousse-Joulin ultrasonography score
Time frame: the day of inclusion
Echostructure of the two salivary glands will be graded 0 to 4 and the size calculated.
4 secondary outcomes
Ultrasonography score equal or higher than 2 on at least one salivary gland
Time frame: the day of inclusion
Ultrasonography score equal or higher than 3 on at least one salivary gland
Time frame: the day of inclusion
Global ultrasonography score higher than 6/16
Time frame: the day of inclusion
Salivary glands area
Time frame: the day of inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis and Gougerot Sjogren Syndrome, run by University Hospital, Clermont-Ferrand at 1 site 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jousse-Joulin ultrasonography score (time frame: the day of inclusion). 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 1 May 2018.