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CTRI Number  CTRI/2026/03/105511 [Registered on: 06/03/2026] Trial Registered Prospectively
Last Modified On: 10/04/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Evaluation of Blood Biomarkers (KL-6 and Telomere Length) for Predicting Outcomes in Interstitial Lung Disease 
Scientific Title of Study   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 Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Asmita Mehta 
Designation  Professor and Head 
Affiliation  Amrita institute of medical science  
Address  Room no. 5, Department of Respiratory Medicine, G-Block

Ernakulam
KERALA
682041
India 
Phone  9037450374  
Fax    
Email  drasmitamehta2026@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Asmita Mehta 
Designation  Professor and Head 
Affiliation  Amrita institute of medical science  
Address  Room no. 5, Department of Respiratory Medicine, G-Block

Ernakulam
KERALA
682041
India 
Phone  9037450374  
Fax    
Email  drasmitamehta2026@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Asmita Mehta 
Designation  Professor and Head 
Affiliation  Amrita institute of medical science  
Address  Room no. 5, Department of Respiratory Medicine, G-Block

Ernakulam
KERALA
682041
India 
Phone  9037450374  
Fax    
Email  drasmitamehta2026@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Amrita Institute of Medical Sciences and Research Centre 
Address  Amrita Institute of Medical Sciences and Research Centre, Ponekkara, Kochi, 682041 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Asmita Mehta  Amrita Institute of Medical Sciences  Room No. 5, G- Block, Department of Respiratory Medicine
Ernakulam
KERALA 		 9037450374

drasmitamehta2026@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee of Amrita School of Medicine  Approved 
Institutional Ethics Committee The Calcutta Medical Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No known chronic respiratory disease No evidence of ILD on imaging (if performed for other clinical reasons)  
Patients  (1) ICD-10 Condition: J848||Other specified interstitial pulmonary diseases, (2) ICD-10 Condition: J989||Respiratory disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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. 		 At Baseline, 3 months, 6 months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
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
 		 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.  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)
 		 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.  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) 		 At Baseline, 3 months, 6 months & 12 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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