Health Condition 1: J848- Other specified interstitial pulmonary diseases Health Condition 2: J989- Respiratory disorder, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Amrita Institute of Medical Sciences and Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: ILD Cohort: Clinically suspected or confirmed ILD based on multidisciplinary assessment, incorporating clinical, radiologic, and (when available) histopathologic data Both IPF (UIP pattern) and non-IPF ILDs eligible for inclusion Ability to provide written informed consent Non-ILD Respiratory Disease Controls: Confirmed chronic respiratory disease (asthma, COPD, bronchiectasis, post-infectious airway disease) without evidence of ILD on high-resolution CT Ability to provide written informed consent Non-Respiratory / Healthy Controls: No known chronic respiratory disease No evidence of ILD on imaging (if performed for other clinical reasons) Ability to provide written informed consent
Exclusion criteria
Exclusion criteria: Acute systemic infections (sepsis, active pneumonia) at time of baseline enrollment Active malignancy or recent oncologic treatment (within 6 months) likely to affect KL6 or telomere levels Significant uncontrolled cardiac disease (acute coronary syndrome, decompensated heart failure) or advanced renal failure (eGFR more than 30 mL/min) Major surgery or significant trauma within preceding 3 months Pregnant or breastfeeding women Any condition that, in the opinion of the investigator, precludes safe participation or may confound biomarker interpretation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate serum KL-6 levels to predict 12-month ILD progression. Assess serial KL-6 for monitoring response to antifibrotic (pirfenidone, nintedanib) or immunosuppressive therapy. Investigate baseline and serial telomere length with ILD progression, treatment response, and outcomes. Explore combined KL-6 and telomere length for improved ILD phenotyping and risk stratification.Timepoint: At Baseline, 3 months, 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the utility of KL-6 as a diagnostic biomarker for differentiating: ILD vs non-ILD chronic respiratory diseases (asthma, COPD, bronchiectasis) IPF/UIP pattern ILD vs non-IPF/non-UIP ILD subtypes Inflammatory vs fibrotic-predominant phenotypes Timepoint: At Baseline, 3 months, 6 months & 12 months;To evaluate changes in KL6 & telomere length during acute exacerbations of ILD & their potential role in early detection of exacerbation events.Timepoint: At Baseline, 3 months, 6 months & 12 months;To explore subgroup differences in biomarker levels according to: Age, sex, & smoking status CT pattern (UIP vs NSIP vs other patterns) Disease duration & treatment history Major comorbidities (connective tissue disease, immunosuppressive therapy use) Timepoint: At Baseline, 3 months, 6 months & 12 months;To establish reference ranges for KL-6 & telomere length in an Indian ILD population with appropriate healthy & disease controls.Timepoint: At Baseline, 3 months, 6 months & 12 months;To correlate KL-6 & telomere length measurements with Disease severity indices i.e GAP (Gender, Age, Physiology) stage; Composite Physiological Index (CPI) High-resolution CT (HRCT) severity scores & fibrosis extent Patient-reported outcomes (K-BILD & SGRQ) Pulmonary function test parameters (FVC, DLCO, FEV1/ FVC ratio)Timepoint: At Baseline, 3 months, 6 months & 12 months | — |
Countries
India
Contacts
Public ContactDr Asmita Mehta
Amrita institute of medical science
Outcome results
None listed