Blood markers may spot Kids' lung disease earlier

NCT ID NCT07559435

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 two substances in the blood, IL-6 and MMP-7, can help doctors diagnose and predict the course of a rare lung disease in children. Researchers will measure these markers in 60 children with immune-mediated interstitial lung disease and compare them to healthy controls. The goal is to improve early detection and treatment planning.

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 simple blood test to help doctors diagnose and predict the course of lung disease in children.
What could go wrong
This is a small, early-stage study with only 60 participants, so results may not apply to all children. The biomarkers may not prove reliable enough for routine use.

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 60 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 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

Group 1: Immune-mediated ILD Pediatric patients with confirmed interstitial lung disease associated with immune-mediated disorders, including: * Connective tissue diseases (CTD) such as SLE, juvenile idiopathic arthritis, juvenile dermatomyositis, mixed connective tissue disease, systemic sclerosis * Vasculitis-associated ILD * Sarcoidosis-associated ILD * Autoimmune musculoskeletal disorders with ILD Group 2: Immune-mediated disease without ILD Pediatric patients with immune-mediated diseases (CTD, vasculitis, sarcoidosis, autoimmune musculoskeletal disorders) but without ILD. This group serves as a comparison to determine whether elevations in IL-6 and MMP-7 are specific to ILD rather than the underlying immune disease itself. Group 3: Healthy Controls Age- and sex-matched healthy children without immune-mediated disease or lung disease used as a baseline reference for biomarker levels.

Ages

2 to 18 years

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: * Children aged 2-18 years with immune-mediated interstitial lung disease, including: * Connective Tissue Disease-associated ILD (CTD-ILD), such as Juvenile Idiopathic Arthritis, according to ILAR Classification, 2019, Systemic Lupus Erythematosus, according to EULAR/ACR Classification, 2023, Juvenile Dermatomyositis, according to EULAR/ACR Classification for Juvenile Idiopathic Inflammatory Myopathies, 2017, Mixed Connective Tissue Disease, according to Kasukawa Criteria, 2019, and Systemic Sclerosis, according to ACR/EULAR Classification, 2013. * Pediatric vasculitis, according to EULAR/PRINTO/PReS Pediatric Vasculitis Classification Criteria, 2022 update. * Pediatric sarcoidosis, according to WASOG pediatric consensus, 2019 * Children with newly diagnosed or previously diagnosed cases in whom IL-6 and MMP- 7 biomarker levels can be obtained according to standardized procedures. * Children whose guardians have provided written informed consent, according to institutional ethical guidelines. Exclusion Criteria: * • ILD caused by infectious, environmental, drug-induced, or post-injury etiologies, rather than immune-mediated mechanisms, according to ERS/ATS chILD guidelines, 2025. * Patients with incomplete diagnostic documentation preventing confirmation according to recognized criteria, as per disease-specific guidelines mentioned above. * Children with other chronic lung diseases unrelated to immune-mediated pathology, such as congenital malformations or cystic fibrosis, according to pediatric pulmonology consensus, 2024. * Cases in which biomarker samples cannot be obtained or processed reliably, according to laboratory standards for IL-6 and MMP-7 measurement

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Juvenile dermatomyositis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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 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 ↗

  2. 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.

More trials for these conditions

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