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RECRUITINGINTERVENTIONAL

Ultra-High Frequency Ultrasonography in Sjögren's Syndrome

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - pregnancy or breastfeeding - any acute or chronic condition that would limit the ability of the patient to participate in the study - refusal to give willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Treatments Being Tested

OTHER

Ultra-High Frequency Ultrasound scan of minor salivary glands

Patients 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.

Locations (1)

University of Pisa
Pisa, Italy