Ultra-High Frequency Ultrasonography in Sjögren's Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pisa

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Ultra-High Frequency Ultrasound scan of minor salivary glands

    Other intervention

    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.

Treatment groups

800 Participants
are divided into 1 treatment group
Group A: Sjogren's syndromeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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 )

Time frame
1 month
2

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

Time frame
1 month

Secondary outcomes

Other outcomes

Sponsors and contacts

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