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CTRI Number  CTRI/2024/10/075938 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 07/05/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Evaluating the Effectiveness of a Multi-Cancer Screening Test in Newly Diagnosed Cancer Patients 
Scientific Title of Study   Evaluation of multi-cancer screening through breath samples performed by biomedical detection dogs in India  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akash Kulgod 
Designation  Founder and CEO 
Affiliation  Vigilomics Bioscience Private Limited 
Address  Plot No 3 Hanuman Nagar Double Road Belgaum Karnataka 590001

Belgaum
KARNATAKA
590001
India 
Phone  7349112424  
Fax    
Email  akash@dognosis.tech  
 
Details of Contact Person
Scientific Query  
Name  Minal Dakhave 
Designation  Medical Affairs Consultant 
Affiliation  Vigilomics Bioscience Private Limited 
Address  Plot No 3 Hanuman Nagar Double Road Belgaum Karnataka 590001

Belgaum
KARNATAKA
590001
India 
Phone  9881894209  
Fax    
Email  admin@vigilomics.com  
 
Details of Contact Person
Public Query  
Name  Minal Dakhave 
Designation  Medical Affairs Consultant 
Affiliation  Vigilomics Bioscience Private Limited 
Address  Plot No 3 Hanuman Nagar Double Road Belgaum Karnataka 590001

Belgaum
KARNATAKA
590001
India 
Phone  9881894209  
Fax    
Email  admin@vigilomics.com  
 
Source of Monetary or Material Support  
Vigilomics Biosciences Private Limited,Plot No 3, Hanuman Nagar, Double Road, Belgaum, India - 590001  
 
Primary Sponsor  
Name  Vigilomics Biosciences Private Limited 
Address  Plot No 3 Hanuman Nagar Double Road Belgaum Karnataka 590001  
Type of Sponsor  Other [Clinical Research] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Somashekhar S P  Aster CMI Bangalore  Department of Oncology, 43/2 NH 7 New Airport Road Sahakar Nagar Sanjeevini Nagar Bengaluru Karnataka 560092
Bangalore
KARNATAKA 		 9845712012

somashekhar.sp@asterhospital.com 
Dr Basavaraj R Patil  Karnataka Cancer Therapy and Research Institute Hubballi  Department of Oncology, KCTRI Main Road Navanagar Hubballi Karnataka 580025
Dharwad
KARNATAKA 		 9448122258

kctrihubli@gmail.com 
Dr K Shridhar  Karnataka Medical College and Research Institute, Hubballi  Department of Oncology, PB Rd, Vidya Nagar, Hubballi, Karnataka 580022
Dharwad
KARNATAKA 		 9448469608

drshashidharkallappa75@gmail.com 
Dr Swaratika Majumdar  Narayana Health, Bangalore  Department of Oncology, 258/A, Bommasandra Industrial Area Anekal, Hosur Rd, Bengaluru, Karnataka 560099
Bangalore
KARNATAKA 		 8105268637

swaratika.majumdar.dr@narayanahealth.org 
Dr Sanjeev Kulgod  Radon Cancer Centre, Hubballi  Department of Oncology, 65, Javalli Garden, Off Gokul Road, Near Suchirayu Hospital, Hubballi, Karnataka 580021
Dharwad
KARNATAKA 		 9342217925

sanjeevkulgod@hotmail.com 
Dr Rakesh S Ramesh  St Johns Medical College Hospital  Department of Oncology, Sarjapur Road, Bangalore 560034
Bangalore
KARNATAKA 		 9980007455

rakesh.sm@stjohns.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Aster CMI Hospital Institutional Ethics Committee  Approved 
Institutional Ethics Committee ST JOHNS MEDICAL COLLEGE HOSPITAL SARJAPUR ROAD BANGALORE  Approved 
KIMS Ethics committee, Hubballi Dharwad  Approved 
KIMS Ethics committee, Hubballi Dharwad  Approved 
NARAYANA HEALTH MEDICAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J40-J47||Chronic lower respiratory diseases, (2) ICD-10 Condition: D10-D36||Benign neoplasms, except benign neuroendocrine tumors, (3) ICD-10 Condition: N17-N19||Acute kidney failure and chronic kidney disease, (4) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (5) ICD-10 Condition: N30-N39||Other diseases of the urinary system, (6) ICD-10 Condition: E08-E13||Diabetes mellitus, (7) ICD-10 Condition: K74||Fibrosis and cirrhosis of liver, (8) ICD-10 Condition: K70-K77||Diseases of liver, (9) ICD-10 Condition: K50-K52||Noninfective enteritis and colitis, (10) ICD-10 Condition: B15-B19||Viral hepatitis, (11) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (12) ICD-10 Condition: B35||Dermatophytosis, (13) ICD-10 Condition: B37||Candidiasis, (14) ICD-10 Condition: N41||Inflammatory diseases of prostate, (15) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, (16) ICD-10 Condition: L97||Non-pressure chronic ulcer of lower limb, not elsewhere classified, (17) ICD-10 Condition: L98||Other disorders of skin and subcutaneous tissue, not elsewhere classified, (18) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract, (19) ICD-10 Condition: R196||Halitosis, (20) ICD-10 Condition: R21||Rash and other nonspecific skin eruption, (21) ICD-10 Condition: Z79||Long term (current) drug therapy, (22) ICD-10 Condition: E00-E07||Disorders of thyroid gland, (23) ICD-10 Condition: Z32||Encounter for pregnancy test and childbirth and childcare instruction, (24) ICD-10 Condition: J84||Other interstitial pulmonary diseases, (25) ICD-10 Condition: G10-G14||Systemic atrophies primarily affecting the central nervous system, (26) ICD-10 Condition: G30||Alzheimers disease, (27) ICD-10 Condition: G80||Cerebral palsy, (28) ICD-10 Condition: G20||Parkinsons disease, (29) ICD-10 Condition: G40-G47||Episodic and paroxysmal disorders, (30) ICD-10 Condition: C50||Malignant neoplasm of breast, (31) ICD-10 Condition: C34||Malignant neoplasm of bronchus andlung, (32) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (33) ICD-10 Condition: C60-C63||Malignant neoplasms of male genital organs, (34) ICD-10 Condition: C64||Malignant neoplasm of kidney, except renal pelvis, (35) ICD-10 Condition: C51||Malignant neoplasm of vulva, (36) ICD-10 Condition: C62||Malignant neoplasm of testis, (37) ICD-10 Condition: C64||Malignant neoplasm of kidney, except renal pelvis, (38) ICD-10 Condition: C22||Malignant neoplasm of liver and intrahepatic bile ducts, (39) ICD-10 Condition: C15||Malignant neoplasm of esophagus, (40) ICD-10 Condition: C71||Malignant neoplasm of brain, (41) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, (42) ICD-10 Condition: C43||Malignant melanoma of skin, (43) ICD-10 Condition: C81-C96||Malignant neoplasms of lymphoid, hematopoietic and related tissue, (44) ICD-10 Condition: C40-C41||Malignant neoplasms of bone and articular cartilage, (45) ICD-10 Condition: C45-C49||Malignant neoplasms of mesothelial and soft tissue, (46) ICD-10 Condition: C16||Malignant neoplasm of stomach, (47) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (48) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs, (49) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (50) ICD-10 Condition: C43-C44||Melanoma and other malignant neoplasms of skin, (51) ICD-10 Condition: C07||Malignant neoplasm of parotid gland, (52) ICD-10 Condition: C68||Malignant neoplasm of other and unspecified urinary organs, (53) ICD-10 Condition: C52||Malignant neoplasm of vagina, (54) ICD-10 Condition: C90||Multiple myeloma and malignant plasma cell neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Case inclusion criteria: Confirmed cancer diagnosis via tissue biopsy and/or pathologist report. Willingness to consent to study participation

Control inclusion criteria: Able to provide consent.
1 No known medical condition or
2 Diagnosed with chronic obstructive pulmonary disease or other pulmonary conditions or Chronic kidney disease or other nephrology conditions or
3 Underwent biopsy with suspected cancer with non malignant report 
 
ExclusionCriteria 
Details  Case exclusion criteria: Patients who have already initiated cancer treatments

Control exclusion criteria for all groups:
1 previous cancer diagnosis at any point
2 Diagnosis of communicable diseases like TB that can be transmitted via breath or sputum
3 Pregnant women or those who gave birth in last three months 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1Cancer type Performance Evaluation The performance of BreathEasy will be critically evaluated to determine its ability to detect multiple types of newly diagnosed cancer through breath samples with the aim of ascertaining its accuracy and reliability in the screening process
2Stage wise Performance Analysis The performance of BreathEasy will be analyzed to determine its effectiveness in detecting early versus late stage cancers
 		 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of Lifestyle Variables
The influence of lifestyle factors, such as smoking & chewing tobacco, on the performance of BreathEasy will be investigated to understand potential limitations & identify areas for adjustment in the screening process
 		 12 weeks 
 
Target Sample Size   Total Sample Size="3000"
Sample Size from India="3000" 
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)   05/11/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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
Modification(s)  

This study aims to validate the effectiveness of the BreathEasy test, a breath-based multi-cancer screening test, in India. It addresses key challenges in cancer screening by focusing on affordability, accessibility, and accuracy. The study will involve around 3000 participants across Hubli and Bangalore sites, with breath samples collected and analyzed for volatile organic compounds (VOCs), which are indicative of cancer.

BreathEasy integrates volatolomics - the study of volatile organic compounds (VOCs) emitted from biological samples, with canine olfaction and advanced technologies such as wearable EEG brain-computer interfaces (BCIs) and machine learning. Trained biomedical detection dogs, equipped with these devices, detect specific cancer-related VOCs, while machine learning models analyze their neural responses to identify cancer biomarkers. This innovative system capitalizes on the unique "odor print" of diseases, offering a novel, non-invasive approach to cancer detection. 

The study’s double-blind design ensures objectivity, as neither handlers nor experimenters know which samples are cancer-positive. Key objectives include evaluating the sensitivity and specificity of canine detection, particularly in early-stage cancers, and exploring the influence of lifestyle factors like smoking on detection accuracy. The study is expected to provide a cost-effective and scalable cancer screening tool, laying the foundation for broader integration of canine-assisted diagnostics into India’s healthcare system, especially in regions with limited access to advanced medical facilities. 



 
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