About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Ultra-High Frequency Ultrasound scan of minor salivary glands
Other interventionPatients will undergo ultra-high frequency ultrasonography (70 MHz) of minor salivary glands, and the scans will be assessed using the OMERACT scoring system. Score 0 will be assigned in the presence of normal glandular tissue, Score 1 will correspond to mild glandular alteration, fine echogenicity or diffuse hypo-echogenicity, Score 2 will be assigned to moderate glandular alteration and focal hypoechoic areas with partial conservation of normal parenchyma, while in Score 3 diffuse presence of hypoechoic areas in the absence of normal glandular parenchyma with glandular fibrosis will be observed.
Treatment groups
Trial outcomes
Primary outcomes
OMERACT score
Evaluation of ultrasonographic scans with the Outcome Measures in Rheumatology (OMERACT) scoring system, ranging between Score 0 (normal glandular tissue) and 3 (diffuse presence of hypoechoic areas in the absence of normal glandular parenchyma with glandular fibrosis )
Correspondence between ultrasonography and histology
Evaluation of the concordance between ultrasonographic score of minor salivary glands assessed with Outcome Measures in Rheumatology (OMERACT) scoring system (scores 0-3) and histology
Sponsors and contacts
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