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CTRI Number  CTRI/2025/11/097242 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 10/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study to identify inflammation-related proteins in lung fluid and blood of tuberculosis patients to develop simpler diagnostic tests. 
Scientific Title of Study   Unveiling host proteomic signatures in bronchoalveolar lavage fluid (BALF) of active pulmonary tuberculosis: Towards development of serum based diagnostic tools 
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 Krishnapriya P Shankar 
Designation  JUNIOR RESIDENT 
Affiliation  KASTURBA MEDICAL COLLEGE, MANIPAL 
Address  DEPARTMENT OF BIOCHEMISTRY KASTURBA MEDICAL COLLEGE, TIGER CIRCLE ROAD, MADHAV NAGAR, MANIPAL, KARNATAKA

Udupi
KARNATAKA
576104
India 
Phone  09633203827  
Fax    
Email  krishnapriya.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  DR VARASHREE B S 
Designation  PROFESSOR 
Affiliation  KASTURBA MEDICAL COLLEGE, MANIPAL 
Address  DEPARTMENT OF BIOCHEMISTRY KASTURBA MEDICAL COLLEGE, TIGER CIRCLE ROAD, MADHAV NAGAR, MANIPAL, KARNATAKA

Udupi
KARNATAKA
576104
India 
Phone  9901729498  
Fax    
Email  varashree.bs@manipal.edu  
 
Details of Contact Person
Public Query  
Name  DR ARJUN ASOK 
Designation  ASSISTANT PROFESSOR 
Affiliation  KASTURBA MEDICAL COLLEGE, MANIPAL 
Address  DEPARTMENT OF BIOCHEMISTRY KASTURBA MEDICAL COLLEGE, TIGER CIRCLE ROAD, MADHAV NAGAR, MANIPAL, KARNATAKA

Udupi
KARNATAKA
576104
India 
Phone  9496818436  
Fax    
Email  arjun.asok@manipal.edu  
 
Source of Monetary or Material Support  
ICMR GRANT 
 
Primary Sponsor  
Name  ICMR 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
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 Krishnapriya P Shankar  KASTURBA MEDICAL COLLEGE, MANIPAL  ROOM NO.12, FIRST FLOOR, DEPARTMENT OF BIOCHEMISTRY KASTURBA MEDICAL COLLEGE, TIGER CIRCLE ROAD, MADHAV NAGAR, MANIPAL, KARNATAKA
Udupi
KARNATAKA 		 09633203827

krishnapriya.kmcmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 Student Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J989||Respiratory disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients above 18 years, with microbiologically confirmed active pulmonary tuberculosis (sputum smear, CBNAAT, or culture positive), undergoing bronchoscopy for clinical evaluation will be included. 
 
ExclusionCriteria 
Details  Patients with disseminated tuberculosis, extrapulmonary tuberculosis, HIV-positive individual, autoimmune diseases, malignancies, chronic inflammatory conditions, on immunosuppressive therapy, chemotherapy, chronic corticosteroids, critically ill patients unfit for bronchoscopy and pregnant/lactating women will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Differential expression of acute phase proteins in BALF of PTB patients versus controls and evaluation of their presence in paired serum samples to assess diagnostic utility.  Single sample collection per participant: at baseline. Study enrollment and sample collection to occur over 12 months. An initial discovery proteomics analysis will be performed on TB cases and controls; selected biomarkers will subsequently be assayed in the remaining samples. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="172"
Sample Size from India="172" 
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)   01/12/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 study aims to identify specific proteins in the lung fluid of patients with active pulmonary tuberculosis to help develop a simple blood-based test for early diagnosis. Lung fluid samples collected during routine bronchoscopy and blood samples from the same patients and healthy individuals will be analyzed using proteomic methods to find differences in protein levels. A few acute phase proteins showing significant changes will be selected and measured in serum using ELISA to assess their potential as diagnostic markers. The findings may help design easier and safer diagnostic tests for tuberculosis, especially useful in patients who cannot provide sputum samples or have negative sputum results. 
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