| 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
|
|
|
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.
|