Diagnostic and Prognostic Utility of IL-6 and MMP-7 in Pediatric Immune Mediated Interstitial Lung Disease
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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: lamiaa k morssi, assistant lecturer
- Telefonní číslo: 01028979861
- E-mail: drlamyaakamel@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
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.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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:
|
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): Evaluation of: (ground-glass opacities, fibrosis, reticular patterns, bronchiectasis) Scoring system may be applied to quantify ILD severity
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. |
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): 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
|
Interleukin-6 (IL-6): measured using enzyme-linked immunosorbent assay (ELISA) -Matrix Metalloproteinase-7 (MM7): quantified using standardized ELISA kits |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
diagnostic and prognostic utility of interleukin-6 (IL-6) and matrix metalloproteinase-7 (MMP-7) in children with immune-mediated interstitial lung disease (ILD)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
To compare IL-6 and MMP-7 levels among the subgroups
Časové okno: 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.
Časové okno: 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.
Časové okno: 2 years
|
2 years
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB00013006
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Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
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