SjögrenNCT06324578
Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis Disease
An observational study of Sjögren and Autoimmune Thyroid Disease, run by IRCCS Burlo Garofolo at 2 sites in Italy.
Trial summary
The main study hypothesis is that Sjögren Disease (SD), usually considered a disorder typical of adult females, may occur not exceptionally in adolescence or even in childhood as a subclinical process. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Sjögren, Autoimmune Thyroid Disease
- What is being tested?
- AT Testing
- How many people
- 150 participants
- Where
- 2 sitesItaly
- Study dates
- 25 Sep 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with autoimmune thyroiditis and previous diagnosis of SD or pre-SD
Who may be able to join
- Subjects between 0-17 years with autoimmune thyroiditis
- Subjects between 0-17 years with previous diagnosis of SD or pre-SD
Who cannot join
- No informed consent from the patient's guardians
- Active or recent infection within one week
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 1 recruiting
- Recruiting
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, 34137
Alberto Tommasini, MD PhD Prof, +39.040.785.422, alberto.tommasini@burlo.trieste.it
Barbara Bonifacio, +39.040.3785.422, barbara.bonifacio@burlo.trieste.it
- Active, not recruiting
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
Udine
About this study
Official title: A Cross-sectional Observational Study, Based on Immunological and Ultrasonographic Evaluations, to Define the Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis.
The main study hypothesis is that Sjögren Disease (SD), usually considered a disorder typical of adult females, may occur not exceptionally in adolescence or even in childhood as a subclinical process. There are several pieces of evidence in favor of this hypothesis, from the incidental detection of asymptomatic SD in pediatric age to biobank-based studies showing that biological signs of SD may precede the disease clinical onset by years or decades. The best scenario to verify this hypothesis could be that of autoimmune thyroiditis, for the following three reasons: 1) subjects with Autoimmune thyroiditis (AT) have a high risk of developing SD (7%); 2) in cases with comorbidity of SD and AT the diagnosis of AT had usually been made before; 3) subjects with AT routinely undergo periodic blood examination and neck ultrasonography (US), which may include Salivary Gland Ultrasound (SGUS) providing contributive data to detect an asymptomatic pre-SD. The knowledge of the real association between AT and pre-SD may impact on several aspects of medicine.
- Conditions
- Sjögren, Autoimmune Thyroid Disease
- Being tested
- AT Testing
- Keywords
- Autoimmune Thyroiditis, Sjögren disease, Immune dysregulation disorders
- Medical subject headings
- Sjogren's Syndrome, Thyroiditis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT TestingDiagnostic test
Analysis of blood specimens and neck ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| subjects with AT | Not described Receives: Diagnostic Test: AT Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of pre-SD in pediatric subjects with AT
Pre-SD will be considered in cases with positive Anti-Sjögren's Syndrome A/Anti-Sjögren's Syndrome B antibodies and a positive Outcome Measures in Rheumatology (OMERACT) score at SGUS and/or a "Focus score" ≥1 at labial salivary gland (LSG) or parotid gland biopsy.
Pre-SD definition meets the American college of rheumatology (ACR)/European league against rheumatism (EULAR) classification criteria for Sjogren Disease if symptoms suspicious of SD are present.
Non-SD Sialadenitis is defined by a positive SGUS with negative SD related antibodies
Measured: At the enrolment (T0)
Prevalence of pre-SD in pediatric subjects with AT
Pre-SD will be considered in cases with positive Anti-Sjögren's Syndrome A/Anti-Sjögren's Syndrome B antibodies and a positive Outcome Measures in Rheumatology (OMERACT) score at SGUS and/or a "Focus score" ≥1 at labial salivary gland (LSG) or parotid gland biopsy.
Pre-SD definition meets the American college of rheumatology (ACR)/European league against rheumatism (EULAR) classification criteria for Sjogren Disease if symptoms suspicious of SD are present.
Non-SD Sialadenitis is defined by a positive SGUS with negative SD related antibodies
Measured: 12 months after the enrolment (T12)
Prevalence of pre-SD in pediatric subjects with AT
Pre-SD will be considered in cases with positive Anti-Sjögren's Syndrome A/Anti-Sjögren's Syndrome B antibodies and a positive Outcome Measures in Rheumatology (OMERACT) score at SGUS and/or a "Focus score" ≥1 at labial salivary gland (LSG) or parotid gland biopsy.
Pre-SD definition meets the American college of rheumatology (ACR)/European league against rheumatism (EULAR) classification criteria for Sjogren Disease if symptoms suspicious of SD are present.
Non-SD Sialadenitis is defined by a positive SGUS with negative SD related antibodies
Measured: 24 months after the enrolment (T24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start25 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SjögrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324578
- Sponsor's protocol ID
- RC 25/2023
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Observational Study, Based on Immunological and Ultrasonographic Evaluations, to Define the Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis.
- ClinicalTrials.gov ID
- NCT06324578
- Acronym / sponsor ID
- RC 25/2023
- Conditions
- Sjögren, Autoimmune Thyroid Disease
- Keywords
- Autoimmune Thyroiditis, Sjögren disease, Immune dysregulation disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main study hypothesis is that Sjögren Disease (SD), usually considered a disorder typical of adult females, may occur not exceptionally in adolescence or even in childhood as a subclinical process. There are several pieces of evidence in favor of this hypothesis, from the incidental detection of asymptomatic SD in pediatric age to biobank-based studies showing that biological signs of SD may precede the disease clinical onset by years or decades. The best scenario to verify this hypothesis could be that of autoimmune thyroiditis, for the following three reasons: 1) subjects with Autoimmune thyroiditis (AT) have a high risk of developing SD (7%); 2) in cases with comorbidity of SD and AT the diagnosis of AT had usually been made before; 3) subjects with AT routinely undergo periodic blood examination and neck ultrasonography (US), which may include Salivary Gland Ultrasound (SGUS) providing contributive data to detect an asymptomatic pre-SD. The knowledge of the real association between AT and pre-SD may impact on several aspects of medicine.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects with AT | – | Diagnostic Test: AT Testing |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with autoimmune thyroiditis and previous diagnosis of SD or pre-SD
Key inclusion criteria (2 listed)
- Subjects between 0-17 years with autoimmune thyroiditis
- Subjects between 0-17 years with previous diagnosis of SD or pre-SD
Key exclusion criteria (2 listed)
- No informed consent from the patient's guardians
- Active or recent infection within one week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AT TestingAnalysis of blood specimens and neck ultrasonography | Diagnostic test | subjects with AT |
Primary outcome
Prevalence of pre-SD in pediatric subjects with AT
Time frame: At the enrolment (T0)
Pre-SD will be considered in cases with positive Anti-Sjögren's Syndrome A/Anti-Sjögren's Syndrome B antibodies and a positive Outcome Measures in Rheumatology (OMERACT) score at SGUS and/or a "Focus score" ≥1 at labial salivary gland (LSG) or parotid gland biopsy. Pre-SD definition meets the American college of rheumatology (ACR)/European league against rheumatism (EULAR) classification criteria for Sjogren Disease if symptoms suspicious of SD are present. Non-SD Sialadenitis is defined by a positive SGUS with negative SD related antibodies
Prevalence of pre-SD in pediatric subjects with AT
Time frame: 12 months after the enrolment (T12)
Pre-SD will be considered in cases with positive Anti-Sjögren's Syndrome A/Anti-Sjögren's Syndrome B antibodies and a positive Outcome Measures in Rheumatology (OMERACT) score at SGUS and/or a "Focus score" ≥1 at labial salivary gland (LSG) or parotid gland biopsy. Pre-SD definition meets the American college of rheumatology (ACR)/European league against rheumatism (EULAR) classification criteria for Sjogren Disease if symptoms suspicious of SD are present. Non-SD Sialadenitis is defined by a positive SGUS with negative SD related antibodies
Prevalence of pre-SD in pediatric subjects with AT
Time frame: 24 months after the enrolment (T24)
Pre-SD will be considered in cases with positive Anti-Sjögren's Syndrome A/Anti-Sjögren's Syndrome B antibodies and a positive Outcome Measures in Rheumatology (OMERACT) score at SGUS and/or a "Focus score" ≥1 at labial salivary gland (LSG) or parotid gland biopsy. Pre-SD definition meets the American college of rheumatology (ACR)/European league against rheumatism (EULAR) classification criteria for Sjogren Disease if symptoms suspicious of SD are present. Non-SD Sialadenitis is defined by a positive SGUS with negative SD related antibodies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjögren and Autoimmune Thyroid Disease, run by IRCCS Burlo Garofolo at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Tommasini, MD PhD Prof (+39.040.3785.422, alberto.tommasini@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of pre-SD in pediatric subjects with AT (time frame: At the enrolment (T0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.