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New blood test could spot autoimmune diseases earlier

NCT ID NCT07188285

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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study will use a special blood test called mass spectrometry to look at immune cells in 500 people with various autoimmune diseases and healthy volunteers. The goal is to find patterns that could help doctors diagnose these conditions sooner. No treatments are being tested; this is purely a research study to gather information.

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 new blood test that helps doctors diagnose autoimmune diseases earlier and more accurately.
What could go wrong
This is an observational study, not a treatment trial. It may not result in a practical diagnostic tool, and findings may not apply to all patients.

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 500 people

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

Started

May 2025

Expected to finish

Sep 2026

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

The patients are in a state of disease activity and do not use biological agents.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Male or female, and aged 18-70 at the time of screening interview (inclusive). 2. The diagnosis of each disease meets the following standards - Systemic lupus erythematosus: 1997 ACR lupus classification standard * Behcet's disease: 2014 ICBD Behcet's disease classification standard * ANCA-associated vasculitis: 1990 American College of Rheumatology Classification Standard * Rheumatoid arthritis: 1987 ARA classification standard * Ankylosing spondylitis: new york standard revised in 1984 * Sjogren's syndrome: 2016 ACR/EULAR Sjogren's syndrome classification standard * Inflammatory myopathy: Bohan recommended criteria in 1977 * Systemic sclerosis: SSc standard formulated by American Rheumatology Association in 1980. * Psoriatic arthritis: CASPAR standard in 2006 * Gouty arthritis: 1997 ACR gout classification standard 3. Disease activity status, each disease should meet the disease activity index; 4. Glucocorticoid (≤1mg/kg/d prednisone or other hormones with equivalent dose) was used before joining the group, and DMARDs (such as methotrexate, hydroxychloroquine, azathioprine, mycophenolate mofetil, leflunomide, cyclosporine, etc.) were allowed; 5. When participating in the trial, the patient must be informed in writing and hope that the patient can abide by the requirements of the research follow-up plan and other protocols. Exclusion Criteria: 1\. Use IVIg or cyclophosphamide within 1.2 months, use other biological agents (infliximab, adalimumab, etanercept, anakinra, etc.) within 3 months, and use rituximab within 6 months; 2.1 months after receiving high-dose glucocorticoid (\> 1 mg/kg/d). 3. Serious complications: including heart failure (≥ NYHA III), renal insufficiency (creatinine clearance rate ≤30 ml/min) and hepatic insufficiency (serum ALT or AST is greater than three times the normal upper limit, or total bilirubin is greater than the normal upper limit). 4\. Other serious, progressive or uncontrollable hematological, gastrointestinal, endocrine, lung, heart, nerve or brain diseases (including demyelinating diseases, such as multiple sclerosis). 5\. Suffering from serious infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or being hospitalized due to infection, or using intravenous antibiotics to treat infection 2 months before the first dose of treatment. 6\. Chest imaging showed abnormalities of malignant tumor or current active infection (including tuberculosis) within 3 months before enrollment. 7\. Infected with HIV(HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If the serum is positive, it is recommended to consult a doctor with expertise in treating HIV or hepatitis C virus infection. 8\. Any known malignant tumor or history of malignant tumor in the past 5 years. 9. Received any vaccination within 3 months before joining the group.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Peking university people's hospital

    Beijing, Beijing Municipality, 100044, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.