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AI reads biopsies to spot Sjogren's syndrome

NCT ID NCT06437652

Diagnosis Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested an artificial intelligence (AI) algorithm designed to analyze images of minor salivary gland biopsies to help diagnose Sjogren's syndrome. Researchers used 1,000 biopsy samples from patients with suspected Sjogren's to see if the AI could accurately count immune cells and measure gland tissue. The goal is to make diagnosis faster and more consistent, and to build a global platform for remote AI-assisted diagnosis.

What this could mean

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

Active substance
Artificial intelligence algorithm
What this could lead to
If successful, this AI could help doctors diagnose Sjogren's syndrome more accurately and quickly from biopsy samples.
What could go wrong
This is a completed validation study; the AI may not perform as well in real-world settings or on different types of images.

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

1,000 people

The number who actually took part.

Started

Oct 2023

Finished

Oct 2024

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 suspected SjS patients presenting with ocular dryness and/or oral dryness, as determined by the American-European Consensus Group (AECG) questions

Ages

18 to 70 years

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: * The original format of digital pathological images of labial gland biopsy tissue from patients with suspected Sjögren's Syndrome uploaded to the designated platform. Exclusion Criteria: 1. Overlapping layers of cells due to excessively thick sections; 2. Excessive tissue defects caused by incomplete sectioning or poor staining on slides; 3. Absence of labial gland; 4. Insufficient clarity in the image.

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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.

Sjogren's syndrome

Contacts and locations

Locations

  • Ying-Qian Mo

    Guangzhou, Guangdong, 510120, China

More trials for these conditions

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