Ultra-High Frequency Ultrasonography in Sjögren's Syndrome

Recruiting now · Not applicable

Conditions studied: Sjogren's Syndrome

In brief

Patients diagnosed with a diagnosis of Sjogren's syndrome performed according to the ACR/EULAR criteria will be included in the study. Sjogren's syndrome diagnosis will be performed following a complete diagnostic work-up involving rheumatologic assessment, glandular functional tests, and blood testing for anti-Ro(SSA) antibodies. Conventional ultrasonography of major salivary glands and ultra-high frequency ultrasonography (70 MHz) of minor salivary glands will be performed, and the scans assessed using the Outcome Measures in Rheumatology (OMERACT) scoring system (Score 0 normal glandular tissue, Score 1 mild glandular alteration, fine echogenicity or diffuse hypo-echogenicity, Score 2 moderate glandular alteration and focal hypoechoic areas with partial conservation of normal parenchyma, Score 3 diffuse presence of hypoechoic areas in the absence of normal glandular parenchyma with glandular fibrosis. Focus Score will be assessed following biopsy of minor salivary glands.

Key facts

Study ID

NCT06338735

Run by

University of Pisa

People needed

800

Starts

2016-01-11

Expected to finish

2030-12-01

Last updated by the study team

2024-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adults ≥ 18 years of age
• clinical suspect of Sjogren\'s syndrome
• acceptance to undergo complete Sjogren\'s Syndrome diagnostic work-up
• acceptance to be included in the study.

You may not qualify if…

• pregnancy or breastfeeding
• any acute or chronic condition that would limit the ability of the patient to participate in the study
• refusal to give informed consent

Where it is running

• University of Pisa — Pisa, Italy (enrolling)

Full record on ClinicalTrials.gov

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