Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338735
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-03-21
Brief Title:
Ultra-High Frequency Ultrasonography in Sjögrens Syndrome
Sponsor:
University of Pisa
Organization:
University of Pisa
Study Overview
Official Title:
Ultra-High Frequency Ultrasonography UHFUS Evaluation of Salivary Glands in Patients With Suspected Sjögrens Syndrome
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UltraSjögren
Brief Summary:
Patients diagnosed with a diagnosis of Sjogrens syndrome performed according to the ACREULAR criteria will be included in the study Sjogrens syndrome diagnosis will be performed following a complete diagnostic work-up involving rheumatologic assessment glandular functional tests and blood testing for anti-RoSSA 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
Detailed Description:
Primary Sjögrens syndrome is a complex autoimmune disease involving the exocrine salivary and lachrymal glands with a progressive functional impairment caused by lymphocytic infiltration in the glandular tissue The diagnosis is currently performed according to the criteria established in 2016 by the American College of RheumatologistsEuropean League Against Rheumatism ACREULAR and relies on 5 items namely i histologic Focus Score FS 1 ii positivity to Anti-SSA Ro antibodies iii Ocular staining score 5 or van Bijsterfeld score 4 on at least one eye iv Schirmer test 5 mm5min on at least one eye and v Unstimulated Salivary Flow Rate USFR 01 mlmin Focus Score and positivity to antibodies are items with a weight of 3 points each while the other items are assigned score 1 Diagnosis is performed with a total score 4 when summing the weights While the improvement in the sensitivity of ACREULAR classification criteria by 5-10 has been previously reported for ultrasonography of major salivary glands at present no evidence is available for minor salivary glands Minor salivary glands ultrasonography with the use of ultra-high frequencies up to 70 MHz has been recently introduced in the diagnostic work-up of Sjögrens syndrome and involves the assessment of glandular ultrasonographic structural alterations through the application of the Outcome Measures in Rheumatology OMERACT scoring system which is routinely used for major salivary glands The present study therefore aims to assess the correlation between minor salivary glands ultrasonography and ACREULAR items in order to evaluate whether this technique may integrate the current evaluation of Sjögrens syndrome patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None