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.
Trial 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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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.
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.
Read more
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.
- 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 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.
- 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.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiaa Kamel Morssi, Sohag University
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 25190079Wynn TA. Integrating mechanisms of pulmonary fibrosis. J Exp Med. 2011 Jul 4;208(7):1339-50. doi: 10.1084/jem.20110551.
PubMed 217271913.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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Utility of IL-6 and MMP-7 in Pediatric Immune Mediated Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07559435
- Acronym / sponsor ID
- IRB00013006
- Keywords
- Pediatric, interstitial lung disease, immune mediated, IL-6, MM-7
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with confirmed interstitial lung disease associated with immune-mediated disorder | – | Diagnostic Test: IL-6 (interlukin 6), Radiation: High-Resolution Computed Tomography (HRCT):, Other: Pulmonary Function Tests (PFTs)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 |
| Patients with immune-mediated disease without ILD | – | Diagnostic Test: IL-6 (interlukin 6), Radiation: High-Resolution Computed Tomography (HRCT):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. |
| Healthy Controls | – | Diagnostic Test: IL-6 (interlukin 6)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 qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- Children aged 2-18 years with immune-mediated interstitial lung disease, including:
- 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.
Key exclusion criteria (4 listed)
- • ILD caused by infectious, environmental, drug-induced, or post-injury etiologies, rather than immune-mediated mechanisms, according to ERS/ATS chILD guidelines, 2025.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL-6 (interlukin 6)Interleukin-6 (IL-6): measured using enzyme-linked immunosorbent assay (ELISA) -Matrix Metalloproteinase-7 (MM7): quantified using standardized ELISA kits | Diagnostic test | 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):High-Resolution Computed Tomography (HRCT): Evaluation of: (ground-glass opacities, fibrosis, reticular patterns, bronchiectasis) Scoring system may be applied to quantify ILD severity | Radiation | Patients with immune-mediated disease without ILD, Pediatric patients with confirmed interstitial lung disease associated with immune-mediated disorder |
| Pulmonary Function Tests (PFTs)Pulmonary Function Tests (PFTs) Spirometry: (FVC, FEV1, FEV1/FVC ratio) | Other | Pediatric patients with confirmed interstitial lung disease associated with immune-mediated disorder |
Primary outcome
diagnostic and prognostic utility of interleukin-6 (IL-6) and matrix metalloproteinase-7 (MMP-7) in children with immune-mediated interstitial lung disease (ILD)
Time frame: 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.
3 secondary outcomes
To compare IL-6 and MMP-7 levels among the subgroups
Time frame: 2 years
To correlate IL-6 and MMP-7 levels with clinical severity, pulmonary function tests, and radiological extent of ILD.
Time frame: 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.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 25190079Tanaka 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.
- Background: PubMed 21727191Wynn TA. Integrating mechanisms of pulmonary fibrosis. J Exp Med. 2011 Jul 4;208(7):1339-50. doi: 10.1084/jem.20110551.
- Background3.Fan LL. Pediatric interstitial lung disease: updates and future directions. Pediatr Pulmonol. 2010;45(8):677-683.
- Background2.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: PubMed 17885266Deutsch 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Immune Mediated Interstitial Lung Disease, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lamiaa k morssi, assistant lecturer (01028979861, drlamyaakamel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic and prognostic utility of interleukin-6 (IL-6) and matrix metalloproteinase-7 (MMP-7) in children with immune-mediated interstitial lung disease (ILD) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07559435, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.