Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome According to the Duration of the Disease

NCT ID: NCT04212572

Last Updated: 2019-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

242 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-20

Study Completion Date

2020-05-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary sjögren's Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Primary sjögren's syndrome ultrasonography salivary glands auto-immune disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHRU de Brest

Brest, , France

Site Status RECRUITING

CHU de LILLE

Lille, , France

Site Status NOT_YET_RECRUITING

CHU de MONTEPELLIER

Montpellier, , France

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Valerie DEVAUCHELLE

Role: CONTACT

Phone: 2 98 34 72 64

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Valerie Devauchelle

Role: primary

Eric Hachulla

Role: primary

Jacques MOREL

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MASAI (29BRC19.0103)

Identifier Type: -

Identifier Source: org_study_id