NCT06338735 Ultra-High Frequency Ultrasonography in Sjögren's Syndrome
| NCT ID | NCT06338735 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pisa |
| Condition | Sjogren's Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2016-01-11 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 800 participants in total. It began in 2016-01-11 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06338735 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sjogren's Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06338735 currently recruiting?
Yes, NCT06338735 is actively recruiting participants. Contact the research team at rossana.izzetti@unipi.it for enrollment information.
Where is the NCT06338735 trial being conducted?
This trial is being conducted at Pisa, Italy.
Who is sponsoring the NCT06338735 clinical trial?
NCT06338735 is sponsored by University of Pisa. The trial plans to enroll 800 participants.