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

NCT07559435 | Not Yet Recruiting

• 1 other identifier: IRB00013006
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Keywords

Pediatric; interstitial lung disease; immune mediated; IL-6; MM-7

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (3)

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

  2 years

• To correlate IL-6 and MMP-7 levels with clinical severity, pulmonary function tests, and radiological extent of ILD.

  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.

  2 years

Study Arms (3)

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

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.

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

Diagnostic Test: IL-6 (interlukin 6)

Interventions

Pulmonary Function Tests (PFTs) OTHER

Pulmonary Function Tests (PFTs) Spirometry: (FVC, FEV1, FEV1/FVC ratio)

Pediatric patients with confirmed interstitial lung disease associated with immune-mediated disorder

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

Healthy Controls; Patients with immune-mediated disease without ILD; Pediatric patients with confirmed interstitial lung disease associated with immune-mediated disorder

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

Patients with immune-mediated disease without ILD; Pediatric patients with confirmed interstitial lung disease associated with immune-mediated disorder

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Related Publications (5)

• 5.Tanaka T, Narazaki M, Kishimoto T. IL-6 in inflammation, immunity, and disease. Cold Spring Harb Perspect Biol. 2014;6:a016295.

  BACKGROUND

• 4.Wynn TA. Integrating mechanisms of pulmonary fibrosis. J Exp Med. 2011;208(7):1339-1350

  BACKGROUND

• 3.Fan LL. Pediatric interstitial lung disease: updates and future directions. Pediatr Pulmonol. 2010;45(8):677-683.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

lamiaa k morssi, assistant lecturer

CONTACT

01028979861; drlamyaakamel@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04