Prognostic Evaluation and Risk Stratification Using Integrated Serum KL-6 and Telomere Length Biomarkers in Interstitial Lung Disease: A Prospective Multicentre Observational Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
Study Overview
Brief Summary
This prospective, observational cohort study aims to evaluate the diagnostic and prognostic utility of serum KL-6 levels and telomere length in patients with Interstitial Lung Disease (ILD). The study will assess their role in disease progression, treatment response, and risk stratification, focusing on the potential synergistic use of these biomarkers in differentiating ILD subtypes and monitoring clinical outcomes. The study will enroll 200 participants: 100 ILD patients, 50 non-ILD chronic respiratory disease controls, and 50 healthy controls. Participants will undergo baseline clinical assessments, imaging (HRCT), pulmonary function tests, and biomarker analysis (KL-6 and telomere length) at multiple time points over a 12-month period.
The primary objective is to explore the relationship between KL-6 levels, telomere length, and disease progression, while secondary objectives include assessing changes in these biomarkers during acute exacerbations and treatment response. Data will be analyzed using SPSS and R software, with regression models used to evaluate the predictive value of biomarkers for disease outcomes. This study will help establish KL-6 and telomere length as reliable biomarkers for ILD diagnosis, prognosis, and monitoring, particularly in the Indian population, and will provide valuable insights into disease mechanisms and personalized treatment strategies.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
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
- •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.
Investigators
Dr Asmita Mehta
Amrita institute of medical science