Ultra-High Frequency Ultrasonography (UHFUS) Evaluation of Salivary Glands in Patients With Suspected Sjögren's Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
University of Pisa
RECRUITING
Pisa
Contact Information
Primary
Rossana Izzetti
rossana.izzetti@unipi.it
+39050993037
Time Frame
Start Date: 2016-01-11
Estimated Completion Date: 2030-12
Participants
Target number of participants: 800
Treatments
Experimental: Sjogren's syndrome
patients with Sjogren's syndrome diagnosed according to the ACR/EULAR criteria
Sponsors
Leads: University of Pisa

This content was sourced from clinicaltrials.gov