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CTRI Number  CTRI/2023/01/048765 [Registered on: 05/01/2023] Trial Registered Prospectively
Last Modified On: 14/04/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Sample collection translational research 
Study Design  Other 
Public Title of Study   Study of blood and sputum samples of healthy humans and patients for cancer research.  
Scientific Title of Study   Collection of blood and sputum samples from healthy subjects and patients with lung cancer for characterization of cancer biomarkers to develop an early-stage liquid biopsy-based cancer screening test. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Rajalakshmi 
Designation  Manager 
Affiliation  Syngene International Limited 
Address  Clinical development Tower 2 Semicon Park Electronics City Phase 2 Hosur Road Bangalore KARNATAKA 560100 India

Bangalore
KARNATAKA
560100
India 
Phone  9980187480  
Fax    
Email  M.Rajalakshmi@syngeneintl.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Rajalakshmi 
Designation  Manager 
Affiliation  Syngene International Limited 
Address  Clinical development Tower 2 Semicon Park Electronics City Phase 2 Hosur Road Bangalore KARNATAKA 560100 India

Bangalore
KARNATAKA
560100
India 
Phone  9980187480  
Fax    
Email  M.Rajalakshmi@syngeneintl.com  
 
Details of Contact Person
Public Query  
Name  Dr Chetan Tamhankar 
Designation  Vice President 
Affiliation  Syngene International Limited 
Address  Clinical development Tower 2 Semicon Park Electronics City Phase 2 Hosur Road Bangalore KARNATAKA 560100 India

Bangalore
KARNATAKA
560100
India 
Phone  9820023309  
Fax    
Email  chetan.tamhankar@syngeneintl.com  
 
Source of Monetary or Material Support  
Oxford Cancer Analytics England  
 
Primary Sponsor  
Name  Oxford Cancer Analytics 
Address  Oxford Cancer Analytics 696 Bioescalator Innovation building Old road campus Roosevelt Drive Headington Oxford England OX3 7FZ 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajeev Vijayakumar  BGS Gleneagles Global Hospital   Ground floor, Room no. NA, Division clinical Medicine Department Uttarahalli Main road Kengeri Bangalore 560060
Bangalore
KARNATAKA 		 8826197760

rajeeviyengar@yahoo.com 
Dr Raut Shreeniwas Sheelawant  Bharati Vidyapeeth Medical College Hospital & Research Centre   Ground floor, Room no. NA, Division medicine Department of Medicine Pune Satara Road Dhankawadi Pune 411043
Pune
MAHARASHTRA 		 9099407702

shriniatbj@yahoo.co.in 
Dr Ankit Agarwal   Geetanjali cancer Center, Geetanjali Medical College and hospital,  OPD No. 05 Cancer Center , Geetanjali Medical College and Hospital, near Eklingpura Chouraha Manwakhera Udaipur 313001.
Udaipur
RAJASTHAN 		 9731671524

dr.ankitagarwal9@gmail.com 
Dr Priyadarshini Lakshmi K  HCG City Cancer Centre  Department of Medical Oncology 33-25-33, CV Venkata Krishnayya street, Suryarao pet, Vijayawada, Andhra Pradesh-520002
Krishna
ANDHRA PRADESH 		 9966030988

priyadarshini006@gmail.com 
Dr Ravikumar Narayan Wategaonkar  Imperial Multispeciality Hospitals  OPD room No-03, Ground floor, Imperial Multi specialty Hospital, Gate No-1193, Pingle Pride, Nr. Radha Swami Ashram, Chikhali, Pune-411062, Maharashtra.
Pune
MAHARASHTRA 		 9823602626

drravikumarwategaonkar@gmail.com 
Dr Mahesh Kumar Kalloli  KLES Dr. Prabhakar Kore Hospital and MRC  Department of Surgical Oncology Nehru Nagar , Belagavi, Karnataka-590010
Belgaum
KARNATAKA 		 9945014996

mahesh.kalloli@gmail.com 
Dr Sampath Kumar M N  Magnum onco care  First floor room #1 No.110 KH Road,(Lalbagh Double Road) Sudhama Nagara, Bengaluru – 560027
Bangalore
KARNATAKA 		 8792241377

dr.sampathkumar041@gmail.com 
Dr VijayaBhaskar R  Meenakshi Mission Hospital and Research centre   Ground floor, Room No. NA, Division clinical medicine department Madurai Lake area Melur road Madurai 625107 Tamilnadu India
Madurai
TAMIL NADU 		 9443647481

drvijayabhaskar@gmail.com 
Dr Radamadhava K  Prakriya Hospital  Department of Medical Oncology Pillar No.500, Metro station, Nagasandra, Service Road, 8th Mile, Tumkur road, Havanar Layout, Bagalukunte, Karnataka-560073
Bangalore
KARNATAKA 		 9686724368

krmadhava1@gmail.com 
Dr Dinesh Yashwant Rao Pendharkar  Sarvodaya Cancer Institute (Sarvodaya Hospital and Research Centre)  Sector -8, YMCA road, Near Escort Mujesar Metro station, Sector-7, Faridabad, Haryana-121006
Faridabad
HARYANA 		 9987736665

drpendharkar@gmail.com 
Dr Vijay Pratap Singh   Savera Cancer and Multispeciality Hospital  OPD -4, Ground Floor, Department of Surgical Oncology, Savera Cancer & Multispeciality Hospital, Near Dr. R N Singh Road, Rajendra Nagar Over Bridge, Kankarbagh, Patna, Bihar 800020
Patna
BIHAR 		 9835066460

vijaypsingh_2000@yahoo.com 
Dr Lokanatha D  Shettys Hospital  Plot No 11 and 12 12TH Floor, Room No. 01, Division clinical clinical department Main Kaveri Nagar Kodichikkanahalli Bommanahalli Bangalore Karnataka 560068
Bangalore
KARNATAKA 		 9148103232

shettyshospital@gmail.com 
Dr J S Kumar  SRM Medical College Hospital & Research Centre   SRM Centre for Clinical Trials and Research, 3rd Floor E Block Extension, SRM Medical College Hospital and Research Centre,SRM Institute of Science & Technology, SRM Nagar, Kattankulathur Chengalpattu - 603 203.
Kancheepuram
TAMIL NADU 		 9840047678

kumarjs1@srmist.edu.in 
Dr Siddangouda Patil  Syngene International Limited  HPU, Room No. 01, Ground floor and second floor Clinical Development Department Division clinical Tower 1 Semicon Park Phase 2 Electronics City Hosur Road Bangalore 560100 Karnataka
Bangalore
KARNATAKA 		 9980165379

Patilsgpt@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 14  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
Conscience Independent Ethics committee  Approved 
Imperial Ethics Committee  Approved 
Institutional Ethics Committee BGS Global Gleneagles Hospital   Approved 
Institutional Ethics Committee Bharati Vidyapeeth Deemed University   Submittted/Under Review 
Institutional Ethics Committee HCG city cancer centre  Approved 
Institutional Ethics Committee Meenakshi Mission Hospital and Research centre   Approved 
Institutional Ethics Committee, KLE Academy of higher Education and Research (KAHER)  Approved 
Institutional Ethics committee- Savera Cancer and Multispeciality hospital  Approved 
Institutional Ethics committee- SRM Medical College Hospital and Research Centre  Approved 
Prakriya Hospital Institutional Ethics committee  Approved 
PRANAV DIABETES CENTER ETHICS COMMITTEE  Approved 
Sarvodaya Hospital and Research Centre- Institutional Ethics Committee  Submittted/Under Review 
Shettys Hospital Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human volunteers 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders, (2) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Cohort I:
1. Male and/or female subjects aged 50-80 years.
2. Weight not less than 50 kg for male and 45kg for female.
3. Subjects who smoke cigarettes daily for at least 20 years (not necessarily 20 years in a
row).
4. Subjects with smoking history of at least 20 pack-years (can be discontinuous).
(Pack-year is a way to measure the amount a person has smoked over a long period of time. It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked. For example, 1 pack year is equal to smoking 1 pack per day for 1 year, or 2 packs per day for half a year, and so on)
5. If former smoker, the subject has quit smoking within the past 15 years. 10,11
6. Subjects who have not gone through treatments (surgery, drugs, radiation).
7. Subjects or Legally Acceptable Representative (for the subjects with low literacy) who provides informed consent.
8. Free of significant diseases or clinically significant abnormal findings during screening,
medical history, physical examination, 12 Lead Electrocardiogram (12 Lead ECG), chest X-Ray and laboratory evaluations (haematology, serum chemistry, urine analysis).
Cohort II and Cohort III:
1. Patients diagnosed with Stage I/II/III/IV lung cancer, most likely NSCLC
a. Stage I/II lung cancer (Cohort II Only)
b. Stage III/IV lung cancer (Cohort III Only)
2. Male and/or female patients aged 50-80 years.10
3. Patients with smoking history of at least 20 pack-years.
4. If former smoker, the patient has quit smoking within the past 15 years.
5. Patients who have not gone through treatment (surgery, drugs, radiation).
6. Patients or Legally Acceptable Representative (for the patients with low literacy) who
provides informed consent. 
 
ExclusionCriteria 
Details  Cohort I:

1. Subjects with the habit of tobacco chewing.
2. Subjects with previous diagnosis of lung cancer.
3. Subjects with previous history of any kind of cancer diagnosis.
4. Subjects who have completed treatments related to any kind of cancer (surgery, drugs,
radiation).
5. Subjects with recent myocardial infarction (MI) history (within 6 months).
6. Subjects unwilling to be part of the study.
7. Subjects having history or presence for disease markers of Human Immunodeficiency Virus 1 (HIV 1) and 2, Hepatitis B and C and Rapid Plasma Reagin (RPR) test for Syphilis.
8. Subject having difficulty in accessibility of veins for blood sampling and or difficulty with donating blood.
9. Subjects having hypersensitivity toward Albuterol.
10. Matched plasma and sputum samples from the same subject is required for the study.
Priority will be given to the plasma (blood) if sputum is unavailable.
11. Female subjects found to be positive during pregnancy test done prior to commencement of study.
12. Lactating females.
13. Any other medical condition, as per the discretion of the investigator, precludes the subject’s participation in the study.
Cohort II and Cohort III:
1. Patient with the habit of tobacco chewing.
2. Patient with previous diagnosis of lung cancer except stage IV in case of metastasis (spread of cancer to other parts of body). The patient can be included in the stage IV (Cohort III) in case of metastasis.
3. Patient with previous history/treatment of any kind of cancer.
4. Patients who have completed treatments for any kind of cancer (surgery, drugs, radiation).
5. Patients with recent myocardial infarction (MI) history (within 6 months).
6. Patients unwilling to be part of the study.
7. Patients having history or presence for disease markers of HIV 1 and 2, Hepatitis B and C and RPR test for Syphilis.
8. Patients having difficulty in accessibility of veins for blood sampling and or difficulty donating blood
9. Patients having hypersensitivity toward Albuterol.
10. Matched plasma and sputum samples from the same patient are required for the study. Priority will be given to the plasma (blood) if sputum is unavailable.
11. Female patients found to be positive during pregnancy test done prior to commencement of study.
12. Lactating females.
13. Any other medical condition, as per the discretion of the investigator, precludes the patient’s participation in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
there is no primary outcome in this sample collection only observational study. Also there is no intervention involved in the study, Hence objective/endpoint to determine its effect is not applicable.  there is no primary outcome in this sample collection only observational study. Also there is no intervention involved in the study, Hence objective/endpoint to determine its effect is not applicable. 
 
Secondary Outcome  
Outcome  TimePoints 
there is no primary outcome in this sample collection only observational study. Also there is no intervention involved in the study, Hence objective/endpoint to determine its effect is not applicable.  there is no primary outcome in this sample collection only observational study. Also there is no intervention involved in the study, Hence objective/endpoint to determine its effect is not applicable. 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
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)   06/01/2023 
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="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Current study protocol will combine unique machine learning, proteomic, and genetic approaches to develop a cost-effective and minimally invasive liquid biopsy-based test for lung cancer detection. State-of-art mass spectrometry proteomics supplemented by genetic approaches will be applied to provide a comprehensive understanding of liquid biopsy biomarkers (blood and sputum) in patients with high risks for lung cancer. A key innovation in this study is the ability to analyze up to thousands of proteins (~5,00- 2,000) and select for a panel of succinct protein biomarkers. Past studies have not analyzed liquid biopsy proteins at this level of depth and quantity for lung cancer. Mass spectrometry will further enable the analysis of post-translational modifications present in liquid biopsy proteins that could be critical for lung cancer early detection and monitoring. 
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