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CTRI Number  CTRI/2024/07/070628 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 13/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Studying the breath of healthy volunteers and lung cancer patients to identify cancer biomarkers 
Scientific Title of Study   Development of portable SERS setup for lung cancer screening by breath analysis 
Trial Acronym  NOT APPLICABLE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  mahadeva prasad KS 
Designation  Research scholar 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Atomic and Molecular Physics, Academic Block 5, L.G 01, MIT Campus, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9743631361  
Fax    
Email  mahadeva.ks@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aseefhali Bankapur 
Designation  Associate professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Atomic and Molecular Physics, Academic Block 5, L.G 01, MIT Campus, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9916241350  
Fax    
Email  asif.bankapur@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Aseefhali Bankapur 
Designation  Associate professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Atomic and Molecular Physics, Academic Block 5, L.G 01, MIT Campus, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9916241350  
Fax    
Email  asif.bankapur@manipal.edu  
 
Source of Monetary or Material Support  
Department of Atomic and Molecular Physics, Academic Block 5, LG 01, MIT campus, MAHE, Manipal-576104, India 
Department of Science and Technology, Technology Bhavan, New Mehrauli Road, New Delhi-110016, India 
 
Primary Sponsor  
Name  Department of Science and Technology Technology Bhavan New mehrauli road New Delhi  
Address  Department of Science and Technology, Technology Bhavan, New mehrauli road, New Delhi-110016. 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Department of Atomic and Molecular Physics  Department of Atomic and Molecular Physics, Academic Block 05, LG 01, MIT Campus, MAHE Manipal 576104 Udupi, Karnataka  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ananth Pai  Kasturba Medical College  Department of Medical Oncology, Shirdi Sai Baba Cancer Center and Research Block, First Floor, Room Number 40, Manipal 576104
Udupi
KARNATAKA 
9880239139

Ananth.pai@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba College and Kastuba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adult Males and Females 
Patients  (1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Male or female Lung cancer patients with or without chronic obstructive pulmonary disease (COPD)
Lung cancer with COPD is defined as those patients with confirmed lung cancer and their FEV1/FVC ratio less than 70 percent.
Lung cancer without COPD is defined as those patients with confirmed lung cancer and their FEV1/FVC ratio greater than 70 percent. 
 
ExclusionCriteria 
Details  Patients who are unable to exhale for at least 6 seconds during a spirometry-based pulmonary function test for COPD diagnosis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. A portable SERS setup for lung cancer screening by breath analysis.
2. Provides a standardized methodology for the collection of VOCs present in human breath.
3. Detect and measure the lung cancer VOC concentrations present in the exhaled breath of patients.
 
Three years
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   26/07/2024 
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="3"
Months="0"
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  

We have designed and developed a sample cell to collect volatile organic compounds (VOCs) of exhaled breath in an aqueous medium. The developed sample cell is designed to avoid sample loss or contamination and to fulfill the necessary condition to perform surface-enhanced Raman spectroscopy (SERS) experiments through plasmonic self-assembly of metallic nanoparticles to identify the VOCs of lung cancer. The above-mentioned sample cell will be utilized to collect the exhaled breath from the healthy volunteers (research scholars, faculty members, and junior engineers from the Department of Atomic and Molecular Physics) and from the lung cancer patients visiting the Department of Medical Oncology and Department of Respiratory Medicine KMC, Manipal during the OPD visits. The breath sample will be collected after at least 3 to 4 hours of fasting, and the participants are instructed to avoid smoking and alcohol consumption to avoid contamination. While collecting the breath sample, general instructions will be given to blow the breath into the sample cell through the mouthpiece; if necessary, a short demo will be given by the instructor. Immediately after completing 8 to 10 exhalations from the participants, the sample cell will be closed, and the mouthpiece and tube connected to the sample cell will be disposed of.

The collected exhaled breath in the sample cell will be subjected to the in situ SERS measurements using the developed optical setup. It comprises a 785 nm diode laser, an upright microscope, a compact CCD-spectrometer, and the sample cell discussed earlier. The obtained SERS spectra will be compared to discriminate the human breath samples of lung cancer patients from those of healthy volunteers.


 
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