MASAÏ: Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome According to the Duration of the Disease
Sponsor
University Hospital, Brest (Other)
Overall Status
Unknown status
CT.gov ID
NCT04212572
Collaborator
(none)
242
3
6
80.7
13.5
Study Details
Study Description
Brief 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. The objective is to evaluate the modification of ultrasonographic abnormalities according to disease in primary Sjögren syndrome.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
242 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome
Actual Study Start Date
:
Nov 20, 2019
Anticipated Primary Completion Date
:
May 20, 2020
Anticipated Study Completion Date
:
May 20, 2020
Outcome Measures
Primary Outcome Measures
- Presence or absence of parenchymal abdnormalities. [inclusion]
Presence or absence of parenchymal abdnormalities. Scored following a standardized fill and according to disease duration
Secondary Outcome Measures
- Parenchymal abnormalities according to disease activity [inclusion]
Ultrasonography parenchymal abnormalities of salivary gland
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female patient ≥ 18 years
-
Primary sjögren syndrome according of age to 2002 or 2016 classification criteria
Exclusion Criteria:
- Secondary sjögren syndrome
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHRU de Brest | Brest | France | 29609 | |
| 2 | CHU de LILLE | Lille | France | 59037 | |
| 3 | CHU de MONTEPELLIER | Montpellier | France | 34295 |
Sponsors and Collaborators
- University Hospital, Brest
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT04212572
Other Study ID Numbers:
- MASAI (29BRC19.0103)
First Posted:
Dec 27, 2019
Last Update Posted:
Dec 27, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Brest
Additional relevant MeSH terms: