Sjogren's DiseaseETREINTENCT02358213
Evaluation of the Reproducibility Inter-observer of the Ultrasound Anomalies of the Salivary Glands in Sjogren's Disease
A study testing Ultrasound in people with Sjogren's Disease, run by University Hospital, Brest.
Trial summary
This aim of this study is to compare the reproducibility of reading of five international experts concerning the anomalies of the salivary glands. The reproducibility is measure on patients and not on recorded data. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sjogren's Disease
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women from 18 to 80 years old
- Patients recruited during the multidisciplinary consultation of Sjogren's Disease, filling the criteria of Sjogren's Disease or patients having a salivary recidivate pathology and selected players on the basis of their voluntary service to benefit from an ultrasound of the main salivary glands
- The patients will have to be capable of adhering to the protocol of study and of having understood it.
- The patients will have to be capable of giving a signed informed consent, the latter being obtained before the inclusion
Who cannot join
- Not cooperative patient and having refused to sign the informed consent.
- Patient incapable to understand the protocol, under guardianship or under guardianship.
- Unaffiliated patients to the Social Security.
About this study
Official title: Evaluation of the Reproducibility Inter-observer of the Ultrasound Anomalies of the Salivary Glands in Sjogren's Disease : Etude ETREINTE.
This aim of this study is to compare the reproducibility of reading of five international experts concerning the anomalies of the salivary glands.
The reproducibility is measure on patients and not on recorded data.
- Conditions
- Sjogren's Disease
- Being tested
- Ultrasound
- Keywords
- reproductibility
- 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.
UltrasoundProcedure or surgery
Ultrasound examinations are done 5 times
| Study group | Role | What they receive |
|---|---|---|
| Procedure | Other | 5 ultrasounds were done on 20 patients by 5 different sonographers Receives: Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility between experts
The outcome measure will be assessed bythe answer of a questionnaire which will be complete by the 5 international experts.
Measured: 1 day
Secondary outcomes (1)
Reproducibility by the sonographer
The sonographer's reproductibility will be assesses by the answer of a questionnaire which will be complete by the 5 international experts.
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 posted6 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie DEVAUCHELLE, PUPH, Principal investigator, Hospital Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358213
- Sponsor's protocol ID
- RB 14.133 ETREINTE
- Acronym
- ETREINTE
- Status last verified
- Mar 2015
- First submitted
- 26 Jan 2015
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reproducibility Inter-observer of the Ultrasound Anomalies of the Salivary Glands in Sjogren's Disease : Etude ETREINTE.
- ClinicalTrials.gov ID
- NCT02358213
- Acronym / sponsor ID
- ETREINTE / RB 14.133 ETREINTE
- Conditions
- Sjogren's Disease
- Keywords
- reproductibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Feb 2015 (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.
This aim of this study is to compare the reproducibility of reading of five international experts concerning the anomalies of the salivary glands.
The reproducibility is measure on patients and not on recorded data.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Procedure | Other | Procedure: Ultrasound5 ultrasounds were done on 20 patients by 5 different sonographers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women from 18 to 80 years old
- Patients recruited during the multidisciplinary consultation of Sjogren's Disease, filling the criteria of Sjogren's Disease or patients having a salivary recidivate pathology and selected players on the basis of their voluntary service to benefit from an ultrasound of the main salivary glands
- The patients will have to be capable of adhering to the protocol of study and of having understood it.
- The patients will have to be capable of giving a signed informed consent, the latter being obtained before the inclusion
Key exclusion criteria (3 listed)
- Not cooperative patient and having refused to sign the informed consent.
- Patient incapable to understand the protocol, under guardianship or under guardianship.
- Unaffiliated patients to the Social Security.
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 |
|---|---|---|
| UltrasoundUltrasound examinations are done 5 times | Procedure or surgery | Procedure |
Primary outcome
Reproducibility between experts
Time frame: 1 day
The outcome measure will be assessed bythe answer of a questionnaire which will be complete by the 5 international experts.
1 secondary outcome
Reproducibility by the sonographer
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 16 Dec 2015.
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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.
Valérie DEVAUCHELLE, PUPH principal investigator
Hospital Brest
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Sjogren's Disease, run by University Hospital, Brest.
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 4 inclusion and 3 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 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Reproducibility between experts (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 16 Dec 2015.