sjögren DiseaseELSANCT02994797
Ultrasound Elastography of Salivary Glands
An observational study of sjögren Disease, run by University Hospital, Brest at 1 site in France.
Trial summary
Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients with sicca syndrome and pSS. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- sjögren Disease
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Apr 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: male or female more than 18 years old consulting in Doppler unit for sicca syndrome or suspicion of Sjögren syndrome
Who may be able to join
- Male or female
- More than 18 years old
- Consulting in Doppler unit for sicca syndrome or suspicion of Sjögren syndrome
- Consent agreement
Who cannot join
- No consent agreement
- No sicca symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elastometry of the Salivary Glands in Sicca Syndrome
Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients with sicca syndrome and pSS.
- Conditions
- sjögren Disease
- Keywords
- salivary glands, ultrasonography, elastometry, elastography
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary glands elastometry
Measure of elasticity of salivary glands (parotid, submandibular and sublingual) in centimeter per second
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 posted16 Dec 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for sjögren 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994797
- Sponsor's protocol ID
- ELSA
- Acronym
- ELSA
- Status last verified
- Aug 2018
- First submitted
- 7 Jul 2016
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elastometry of the Salivary Glands in Sicca Syndrome
- ClinicalTrials.gov ID
- NCT02994797
- Acronym / sponsor ID
- ELSA / ELSA
- Conditions
- sjögren Disease
- Keywords
- salivary glands, ultrasonography, elastometry, elastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 16 Dec 2016 (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.
Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients with sicca syndrome and pSS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male or female more than 18 years old consulting in Doppler unit for sicca syndrome or suspicion of Sjögren syndrome
Key inclusion criteria (4 listed)
- Male or female
- More than 18 years old
- Consulting in Doppler unit for sicca syndrome or suspicion of Sjögren syndrome
- Consent agreement
Key exclusion criteria (2 listed)
- No consent agreement
- No sicca symptoms
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
salivary glands elastometry
Time frame: 1 day
Measure of elasticity of salivary glands (parotid, submandibular and sublingual) in centimeter per second
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 9 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for sjögren Disease
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Active, not recruitingObservational study
Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome
Primary Sjögren Syndrome, Sarcopenia
Active, not recruitingPhase 2
A Study of RSLV-132 in Females With Sjögren's Disease
Primary Sjögren Syndrome
RecruitingPhase 3
Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden
Sjögren´s Disease
Not yet recruiting
Effectiveness of an Oral Exercise Program for Xerostomia in Patients With Sjögren Disease
Sjogren Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
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 sjögren Disease, 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 4 inclusion and 2 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 9 Jul 2019. 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?
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?
salivary glands elastometry (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 9 Jul 2019.