Primary Sjögren's Syndrome (pSS)DIApSSNCT03681964
Diagnostic Suspicion of Primitive Syndrome Sjögren's : Brest Cohort
An observational study of Primary Sjögren's Syndrome (pSS), run by University Hospital, Brest at 1 site in France.
Trial summary
This study aims to evaluate the diagnosis performance of several item used for the classification, the diagnosis and the prognostic of pSS (primary Sjogren syndrome) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sjögren's Syndrome (pSS)
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2015to 28 Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 suspected pSS underwent a standardised evaluation
Who may be able to join
- Patients with suspected pSS underwent a standardised evaluation
Who cannot join
- Opposition of patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Valerie Devauchelle
About this study
This study aims to evaluate the diagnosis performance of several item used for the classification, the diagnosis and the prognostic of pSS (primary Sjogren syndrome)
- Conditions
- Primary Sjögren's Syndrome (pSS)
What is being measured
The primary outcome is the main question the study is designed to answer.
classification criteria
classification criteria at inclusion of patients with suspected primary Sjögren's syndrome (pSS) underwent with standardised evaluation
Measured: Inclusion (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start28 Sep 2015
- Primary completion28 Sep 2020 (estimated)
- Study completion28 Sep 2030 (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 Syndrome (pSS)Studies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie Devauchelle, Study director, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681964
- Sponsor's protocol ID
- DIApSS
- Acronym
- DIApSS
- Status last verified
- Jul 2018
- First submitted
- 21 Sep 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Suspicion of Primitive Syndrome Sjögren's : Brest Cohort
- ClinicalTrials.gov ID
- NCT03681964
- Acronym / sponsor ID
- DIApSS / DIApSS
- Conditions
- Primary Sjögren's Syndrome (pSS)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 28 Sep 2015 (actual)
- Primary completion
- 28 Sep 2020 (estimated)
- Study completion
- 28 Sep 2030 (estimated)
- First posted
- 24 Sep 2018 (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.
This study aims to evaluate the diagnosis performance of several item used for the classification, the diagnosis and the prognostic of pSS (primary Sjogren 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 suspected pSS underwent a standardised evaluation
Key inclusion criteria (1 listed)
- Patients with suspected pSS underwent a standardised evaluation
Key exclusion criteria (1 listed)
- Opposition of patient
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
classification criteria
Time frame: Inclusion (Day 0)
classification criteria at inclusion of patients with suspected primary Sjögren's syndrome (pSS) underwent with standardised evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 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.
Valerie Devauchelle study director
CHRU de Brest
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 Primary Sjögren's Syndrome (pSS), run by University Hospital, Brest 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 1 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: looking for participants now, as of the sponsor's last update on 24 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valerie Devauchelle, MD,PhD (33 (0) 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?
classification criteria (time frame: Inclusion (Day 0)). 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 24 Sep 2018.