NCT06338735Recruiting
Ultra-High Frequency Ultrasonography in Sjögren's Syndrome
Ultra-High Frequency Ultrasonography (UHFUS) Evaluation of Salivary Glands in Patients With Suspected Sjögren's Syndrome
Source: ClinicalTrials.gov · Last updated 26 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- First submitted
- 21 Mar 2024
- Start date
- 11 Jan 2016
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Pisa
- Diseases
- Sjögren's disease
- NCT number
- NCT06338735
What you commit to
- Study type: Interventional
- Planned participants: 800
- From 11 Jan 2016 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- any acute or chronic condition that would limit the ability of the patient to participate in the study
Other
- pregnancy or breastfeeding
- refusal to give informed consent
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pisa Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.