Pediatric Immune Mediated Interstitial Lung DiseaseNCT07559435

Diagnostic and Prognostic Utility of IL-6 and MMP-7 in Pediatric Immune Mediated Interstitial Lung Disease

An observational study of Pediatric Immune Mediated Interstitial Lung Disease, run by Sohag University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 2 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Pediatric Immune Mediated Interstitial Lung Disease
What is being tested?: IL-6 (interlukin 6), High-Resolution Computed Tomography (HRCT): and Pulmonary Function Tests (PFTs)
Type of treatment: Surgery or procedure
How many people: 60 participants
Where: No sites listed yet
Study dates: 15 Apr 2026to Apr 2028
How long will I take part?: 2 Years
Phase: Observational

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 2 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Study population: 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.

Who may be able to join

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.

Who cannot join

• 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

lamiaa k morssi, assistant lecturer contact

01028979861

drlamyaakamel@gmail.com

About this study

Pediatric interstitial lung disease (ILD) represents a heterogeneous group of rare but potentially severe pulmonary disorders characterized by diffuse parenchymal involvement and impaired gas exchange. Among these, immune-mediated ILD constitutes a significant subgroup, often associated with autoimmune and inflammatory conditions, leading to progressive lung damage and substantial morbidity.

Early diagnosis and accurate prognostication of pediatric ILD remain challenging due to overlapping clinical presentations, nonspecific radiological findings, and the lack of reliable biomarkers. Consequently, there is an increasing need to identify measurable biological indicators that can aid in both diagnosis and prediction of disease progression.

Interleukin-6 (IL-6) is a pro-inflammatory cytokine that plays a central role in immune regulation and has been implicated in various inflammatory and autoimmune disorders. Elevated IL-6 levels have been associated with disease activity and severity in multiple pulmonary conditions. Similarly, matrix metalloproteinase-7 (MMP-7) is involved in extracellular matrix remodeling and has emerged as a promising biomarker in interstitial lung diseases, reflecting ongoing tissue injury and fibrosis.

The combined assessment of IL-6 and MMP-7 may provide valuable insights into both inflammatory activity and fibrotic processes in immune-mediated ILD. This dual role suggests their potential utility not only as diagnostic markers but also as prognostic indicators for disease progression and clinical outcomes.

This study aims to evaluate the diagnostic and prognostic utility of IL-6 and MMP-7 in children with immune-mediated interstitial lung disease, with the goal of improving early detection, risk stratification, and clinical management.

Conditions: Pediatric Immune Mediated Interstitial Lung Disease
Being tested: IL-6 (interlukin 6), High-Resolution Computed Tomography (HRCT):, Pulmonary Function Tests (PFTs)
Keywords: Pediatric, interstitial lung disease, immune mediated, IL-6, MM-7
Medical subject headings: Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IL-6 (interlukin 6)Diagnostic test
Interleukin-6 (IL-6): measured using enzyme-linked immunosorbent assay (ELISA)
-Matrix Metalloproteinase-7 (MM7): quantified using standardized ELISA kits
High-Resolution Computed Tomography (HRCT):Radiation
High-Resolution Computed Tomography (HRCT):
Evaluation of: (ground-glass opacities, fibrosis, reticular patterns, bronchiectasis) Scoring system may be applied to quantify ILD severity
Pulmonary Function Tests (PFTs)Other
Pulmonary Function Tests (PFTs) Spirometry: (FVC, FEV1, FEV1/FVC ratio)

Study groups in NCT07559435
Study group	Role	What they receive
Pediatric patients with confirmed interstitial lung disease associated with immune-mediated disorder		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 Receives: Diagnostic Test: IL-6 (interlukin 6); Radiation: High-Resolution Computed Tomography (HRCT):; Other: Pulmonary Function Tests (PFTs)
Patients with 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. Receives: Diagnostic Test: IL-6 (interlukin 6); Radiation: High-Resolution Computed Tomography (HRCT):
Healthy Controls		Healthy Controls Age- and sex-matched healthy children without immune-mediated disease or lung disease used as a baseline reference for biomarker levels Receives: Diagnostic Test: IL-6 (interlukin 6)

What is being measured

The primary outcome is the main question the study is designed to answer.

diagnostic and prognostic utility of interleukin-6 (IL-6) and matrix metalloproteinase-7 (MMP-7) in children with immune-mediated interstitial lung disease (ILD)
To evaluate the diagnostic and prognostic utility of interleukin-6 (IL-6) and matrix metalloproteinase-7 (MMP-7) in children with immune-mediated interstitial lung disease (ILD), including connective tissue diseases (CTD), vasculitis, and sarcoidosis.
Measured: 2 years

Secondary outcomes (3)

To compare IL-6 and MMP-7 levels among the subgroups
To compare IL-6 and MMP-7 levels among the subgroups:
CTD-associated ILD Vasculitis-associated ILD Sarcoidosis-associated ILD Healthy pediatric controls
Measured: 2 years
To correlate IL-6 and MMP-7 levels with clinical severity, pulmonary function tests, and radiological extent of ILD.
Measured: 2 years
To assess the potential of IL-6 and MMP-7 as non-invasive biomarkers for early detection, disease monitoring, and prognosis in pediatric immune-mediated ILD.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 2026Apr 2028

First posted30 Apr 2026
Study start15 Apr 2026 (estimated)
Primary completionApr 2028 (estimated)
Study completionApr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Pediatric Immune Mediated Interstitial Lung DiseaseStudies 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: Cohort
Time perspective: Prospective
Enrolment: 60 participants (estimated)
Target duration: 2 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT07559435
Sponsor's protocol ID: IRB00013006
Status last verified: Apr 2026
First submitted: 23 Apr 2026
Last updated: 30 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Tanaka T, Narazaki M, Kishimoto T. IL-6 in inflammation, immunity, and disease. Cold Spring Harb Perspect Biol. 2014 Sep 4;6(10):a016295. doi: 10.1101/cshperspect.a016295.
PubMed 25190079
Wynn TA. Integrating mechanisms of pulmonary fibrosis. J Exp Med. 2011 Jul 4;208(7):1339-50. doi: 10.1084/jem.20110551.
PubMed 21727191
3.Fan LL. Pediatric interstitial lung disease: updates and future directions. Pediatr Pulmonol. 2010;45(8):677-683.
2.Biederer J, Schoepf UJ, Mirsadraee S, Schick S, Beer M, Semple S, et al. Pediatric interstitial lung disease: a review with emphasis on connective tissue disease-associated ILD. Radiology. 2012;262(2):623-639.
Deutsch GH, Young LR, Deterding RR, Fan LL, Dell SD, Bean JA, Brody AS, Nogee LM, Trapnell BC, Langston C; Pathology Cooperative Group; Albright EA, Askin FB, Baker P, Chou PM, Cool CM, Coventry SC, Cutz E, Davis MM, Dishop MK, Galambos C, Patterson K, Travis WD, Wert SE, White FV; ChILD Research Co-operative. Diffuse lung disease in young children: application of a novel classification scheme. Am J Respir Crit Care Med. 2007 Dec 1;176(11):1120-8. doi: 10.1164/rccm.200703-393OC. Epub 2007 Sep 20.
PubMed 17885266