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

23. april 2026 opdateret af: Lamiaa Kamel Morssi, Sohag University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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
Diagnostisk test: IL-6 (interlukin 6)

Interleukin-6 (IL-6): measured using enzyme-linked immunosorbent assay (ELISA)

-Matrix Metalloproteinase-7 (MM7): quantified using standardized ELISA kits

Stråling: High-Resolution Computed Tomography (HRCT):

High-Resolution Computed Tomography (HRCT):

Evaluation of: (ground-glass opacities, fibrosis, reticular patterns, bronchiectasis) Scoring system may be applied to quantify ILD severity

Andet: Pulmonary Function Tests (PFTs)
Pulmonary Function Tests (PFTs) Spirometry: (FVC, FEV1, FEV1/FVC ratio)
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.
Diagnostisk test: IL-6 (interlukin 6)

Interleukin-6 (IL-6): measured using enzyme-linked immunosorbent assay (ELISA)

-Matrix Metalloproteinase-7 (MM7): quantified using standardized ELISA kits

Stråling: High-Resolution Computed Tomography (HRCT):

High-Resolution Computed Tomography (HRCT):

Evaluation of: (ground-glass opacities, fibrosis, reticular patterns, bronchiectasis) Scoring system may be applied to quantify ILD severity
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
Diagnostisk test: IL-6 (interlukin 6)

Interleukin-6 (IL-6): measured using enzyme-linked immunosorbent assay (ELISA)

-Matrix Metalloproteinase-7 (MM7): quantified using standardized ELISA kits

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
diagnostic and prognostic utility of interleukin-6 (IL-6) and matrix metalloproteinase-7 (MMP-7) in children with immune-mediated interstitial lung disease (ILD)
Tidsramme: 2 years
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.
2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To compare IL-6 and MMP-7 levels among the subgroups
Tidsramme: 2 years

To compare IL-6 and MMP-7 levels among the subgroups:

CTD-associated ILD Vasculitis-associated ILD Sarcoidosis-associated ILD Healthy pediatric controls
2 years
To correlate IL-6 and MMP-7 levels with clinical severity, pulmonary function tests, and radiological extent of ILD.
Tidsramme: 2 years
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.
Tidsramme: 2 years
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sohag University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • 5.Tanaka T, Narazaki M, Kishimoto T. IL-6 in inflammation, immunity, and disease. Cold Spring Harb Perspect Biol. 2014;6:a016295.
  • 4.Wynn TA. Integrating mechanisms of pulmonary fibrosis. J Exp Med. 2011;208(7):1339-1350
  • 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.
  • 1.Deutsch GH, Young LR, Deterding RR, Fan LL, Dell SD, Reynolds AM, et al. Diffuse lung disease in young children: application of a novel classification scheme. Am J Respir Crit Care Med. 2007;176(11):1120-1128

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. april 2026

Primær færdiggørelse (Anslået)

1. april 2028

Studieafslutning (Anslået)

1. april 2028

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

23. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00013006

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