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Blood test may predict Sjögren's severity

NCT ID NCT07414667

Knowledge-focused Sponsor: Central Hospital, Nancy, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether measuring a specific antibody, anti-Ro52, in the blood of people with Sjögren's syndrome can help predict who will develop serious problems like lymphoma or organ damage. Researchers will follow 150 patients over time to see if higher antibody levels are linked to worse disease activity. The goal is to improve how doctors assess risk and tailor treatment for each patient.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a blood test that helps doctors identify Sjögren's patients at higher risk for serious complications, enabling earlier and more personalized care.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve health. The findings may not change current practice if the antibody levels don't reliably predict outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will include adult patients (≥18 years old) diagnosed with primary Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria. Participants must have had a quantitative measurement of anti-Ro52 antibodies performed as part of routine clinical care since 2020. Eligible patients will be followed in the internal medicine department or other participating units and must provide informed consent or non-opposition to participate. Patients with other systemic autoimmune diseases, prior organ or bone marrow transplantation, severe immunosuppression unrelated to Sjögren's syndrome, incomplete clinical or laboratory data, or under legal protection will be excluded.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria : * Age ≥ 18 years at the time of inclusion, * Diagnosis of primary Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria, * Quantitative measurement of anti-Ro52 antibodies performed as part of routine care, starting from 2020 (date of routine implementation in the laboratory), * Documented medical follow-up in the internal medicine department (or other participating department), * No objection to participation in research after being informed according to current regulations (record of non-opposition if applicable). Exclusion Criteria * Presence of another systemic autoimmune connective tissue disease, including systemic lupus erythematosus, systemic sclerosis, autoimmune myositis, rheumatoid arthritis (except nonspecific arthralgia without classification criteria), * History of solid organ or bone marrow transplantation, * Severe immunosuppression unrelated to Sjögren's syndrome (e.g., HIV infection, ongoing chemotherapy for active hematologic malignancy), * Incomplete or non-exploitable clinical or biological data preventing analysis of primary or secondary endpoints, * Individuals under legal protection measures (e.g., guardianship).

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Conditions

The condition(s) this trial relates to.

Sjogren syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sjögren's syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Université de Nancy

    Vandœuvre-lès-Nancy, 54500, France

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