Primary sjögren's SyndromeMASAÏNCT04212572
Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome According to the Duration of the Disease
An observational study of Primary sjögren's Syndrome, run by University Hospital, Brest at 3 sites in France.
Trial summary
Salivary gland ultrasonography is identified as a valuable diagnostic tool and potential criteria item for disease classification of sjögren's syndrome and evaluate evolution of parenchyma. The investigators have to include 242 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary sjögren's Syndrome
- How many people
- 242 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Nov 2019to 20 May 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Primary sjögren syndrome
Who may be able to join
- Male or female patient ≥ 18 years
- Primary sjögren syndrome according of age to 2002 or 2016 classification criteria
Who cannot join
- Secondary sjögren syndrome
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Valerie Devauchelle, 02 98 34 72 64, valerie.devauchelle-pensec@chu-brest.fr
- Not yet recruiting
CHU de LILLE
Lille, 59037
Eric Hachulla
- Not yet recruiting
CHU de MONTEPELLIER
Montpellier, 34295
Jacques MOREL
About this study
Official title: Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome
Salivary gland ultrasonography is identified as a valuable diagnostic tool and potential criteria item for disease classification of sjögren's syndrome and evaluate evolution of parenchyma.
The investigators have to include 242 patients. The objective is to evaluate the modification of ultrasonographic abnormalities according to disease in primary Sjögren syndrome.
- Conditions
- Primary sjögren's Syndrome
- Keywords
- Primary sjögren's syndrome, ultrasonography, salivary glands, auto-immune disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of parenchymal abdnormalities.
Presence or absence of parenchymal abdnormalities. Scored following a standardized fill and according to disease duration
Measured: inclusion
Secondary outcomes (1)
Parenchymal abnormalities according to disease activity
Ultrasonography parenchymal abnormalities of salivary gland
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start20 Nov 2019
- Primary completion20 May 2020 (estimated)
- Study completion20 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212572
- Sponsor's protocol ID
- MASAI (29BRC19.0103)
- Acronym
- MASAÏ
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2019
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT04212572
- Acronym / sponsor ID
- MASAÏ / MASAI (29BRC19.0103)
- Conditions
- Primary sjögren's Syndrome
- Keywords
- Primary sjögren's syndrome, ultrasonography, salivary glands, auto-immune disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 20 May 2020 (estimated)
- Study completion
- 20 May 2020 (estimated)
- First posted
- 27 Dec 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.
Salivary gland ultrasonography is identified as a valuable diagnostic tool and potential criteria item for disease classification of sjögren's syndrome and evaluate evolution of parenchyma.
The investigators have to include 242 patients. The objective is to evaluate the modification of ultrasonographic abnormalities according to disease in primary Sjögren syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Primary sjögren syndrome
Key inclusion criteria (2 listed)
- Male or female patient ≥ 18 years
- Primary sjögren syndrome according of age to 2002 or 2016 classification criteria
Key exclusion criteria (1 listed)
- Secondary sjögren syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence or absence of parenchymal abdnormalities.
Time frame: inclusion
Presence or absence of parenchymal abdnormalities. Scored following a standardized fill and according to disease duration
1 secondary outcome
Parenchymal abnormalities according to disease activity
Time frame: inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
3 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's Syndrome, run by University Hospital, Brest 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 2 inclusion and 1 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 27 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie DEVAUCHELLE (2 98 34 72 64, valerie.devauchelle-pensec@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of parenchymal abdnormalities. (time frame: 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 27 Dec 2019.