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

23. April 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

60

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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
Diagnosetest: IL-6 (interlukin 6)

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

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

Strahlung: 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

Sonstiges: 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.
Diagnosetest: IL-6 (interlukin 6)

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

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

Strahlung: 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
Diagnosetest: IL-6 (interlukin 6)

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

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
diagnostic and prognostic utility of interleukin-6 (IL-6) and matrix metalloproteinase-7 (MMP-7) in children with immune-mediated interstitial lung disease (ILD)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To compare IL-6 and MMP-7 levels among the subgroups
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 2 years
2 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sohag University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

  • 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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. April 2026

Primärer Abschluss (Geschätzt)

1. April 2028

Studienabschluss (Geschätzt)

1. April 2028

Studienanmeldedaten

Zuerst eingereicht

23. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. April 2026

Zuerst gepostet (Tatsächlich)

30. April 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. April 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB00013006

Plan für individuelle Teilnehmerdaten (IPD)

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Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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