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CTRI Number  CTRI/2025/04/085190 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 10/04/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   This study tests the CanScan Breath Analyzer to detect breast cancer by including both patients (with positive mammography results) and healthy volunteers (with negative results), focusing on how accurately it identifies cancer and rules it out. 
Scientific Title of Study   Clinical Performance Evaluation of CanScan Breath Analyzer for Breast Cancer Screening.  
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 Nagesh Sirsath 
Designation  Consultant Medical Oncogist 
Affiliation  Renatus Cancer Center 
Address  Renatus Cancer Center, Mitra mandal chowk, saras baug rd, opposite patil plaza, Parvati payatha, Pune

Pune
MAHARASHTRA
411002
India 
Phone  8698035501  
Fax    
Email  nagesh.sirsath@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Jilma Peruvangat 
Designation  Director 
Affiliation  Kozhnosys Pvt. Ltd. 
Address  Room No: 5,Dept of Med Regulations, 600 NIP, Kozhnosys Pvt Ltd,100, NCL Innovation Park Pashan, Pune, 411008 Phone No. 9657782663

Pune
MAHARASHTRA
411008
India 
Phone  9833482033  
Fax    
Email  jilma@kozhnosys.com  
 
Details of Contact Person
Public Query  
Name  Jilma Peruvangat 
Designation  Director 
Affiliation  Kozhnosys Pvt. Ltd. 
Address  Room No: 5,Dept of Med Regulations, 600 NIP, Kozhnosys Pvt Ltd,100, NCL Innovation Park Pashan, Pune, 411008 Phone No. 9657782663

Pune
MAHARASHTRA
411008
India 
Phone  9833482033  
Fax    
Email  jilma@kozhnosys.com  
 
Source of Monetary or Material Support  
Company Name-Kozhnosys Private Limited. Address: Kozhnosys Pvt Limited,100,NCL Innovation Park, Dr. Homi Bhabha Road, Pashan, Pune-411008, Maharashtra. 
 
Primary Sponsor  
Name  Kozhnosys Private Limited  
Address  803, A-15, Xrbia Hinjewadi, Nere Dattawadi, Pune-412115 
Type of Sponsor  Other [Biomedical Research Company] 
 
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 Nagesh Sirsat  Renatus Cancer Center  Renatus Cancer Center, FVX3+5H6, Saras Buag Rd, Opposite Sarasbuag, Mitra Mandal colony, Parvati Paytha, Pune 411002
Pune
MAHARASHTRA 		 8698035501

nagesh.sirsath@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Commitee Jehangir Clinical Development Center Pvt. Ltd  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  1)Willing to sign the informed consent form.
2)Females aged 18 years and above.
3)Confirmed cases of breast cancer -positive mammography/breast sonography/breast examination report (but not exposed to any treatment cycle/surgery for tumor removal); and willing to undergo further MRI /biopsy if required.
4)Women with negative mammography/breast sonography reports and willing to undergo further MRI if required.
 
 
ExclusionCriteria 
Details  1)Patients undergoing breast cancer treatment.
2)Patients who have undergone surgery for breast tumor removal.
3)Patients with negative mammography/breast sonography reports.
4)Patients without breast examination report from PI.
5)Pregnant & lactating mothers.
6)Previous history of treated breast cancer, or cancer of any other site, except basal cell carcinoma of the skin.
7)Consumption of alcohol, pan, gutkha within less than 12 hrs.
8)Smoking within the last one month
9)Breast cancer patients who do not share a biopsy report.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sensitivity and specificity:
The study will estimate sensitivity and specificity rates for the CanScan Breath Analyzer in screening all stage breast cancer. This would measure the tool’s effectiveness in correctly distinguishing between breast cancer patients and healthy subject. 		 32 
 
Secondary Outcome  
Outcome  TimePoints 
Breath Test acceptance & subject satisfaction: Highlight the non-invasive nature of the screening method, measuring subject’s ease of use compared to traditional screening methods like mammograms.  4 weeks 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   11/07/2025 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 is a clinical performance evaluation of the CanScan breath analyzer for breast cancer screening study. This study aims to evaluate the CanScan Breath Analyzer’s effectiveness in screening breast cancer. It involves 200 females, divided into two groups of 100 each: the Cancer Group (newly diagnosed breast cancer patients) and the Control Group (females with negative breast cancer screening results). The primary objectives are to assess the screening accuracy and performance of the CanScan Breath Analyzer, including sensitivity, specificity, and accuracy, which would be compared with standard breast screening methods. In contrast, secondary objectives focus on cost-effectiveness, acceptability, and operational feasibility. The study is prospective, non-randomized, and observational, involving a single visit for breath sample collection after 3 hours of fasting. Participants’ demographics, medical history, and relevant information are gathered, and the breath samples are analyzed using the CanScan device. The results are compared with traditional screening methods. The study also includes criteria for subject inclusion and exclusion, emphasizing the importance of obtaining informed consent and ensuring participants meet specific conditions. The study’s outcomes will provide insights into the tool’s screening accuracy, subject acceptance, and operational feasibility, contributing to the potential integration of the CanScan Breath Analyzer into routine clinical practice for breast cancer screening.
 
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