| CTRI Number |
CTRI/2025/12/099452 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of the CanScan Breath Test for Screening Breast Cancer in Women. |
|
Scientific Title of Study
|
Clinical performance evaluation of the 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 Gaurav Jaswal |
| Designation |
Director & Consultant of Radiation Oncology |
| Affiliation |
TGH Onco-life Cancer Center, General Hospital Campus |
| Address |
TGH Onco-life Cancer Center,
General Hospital Campus,
Talegaon Chakan Road, Talegaon Dabhade-410506
Pune
MAHARASHTRA
410506
India |
| Phone |
7009521950 |
| Fax |
|
| Email |
gaurav.jaswal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jilma Peruvangat |
| Designation |
Director |
| Affiliation |
Kozhnosys Pvt. Ltd. |
| Address |
Survey No. 38/2, 38/3, 56:57, Flat No. 803 Building- A,
15 XRBIA, Hinjewadi, Nr Datt, Pune-411215
Kozhnosys Pvt Ltd,
100, NCL Innovation Park, Pashan, Pune, 411008
Pune
MAHARASHTRA
411215
India |
| Phone |
9657782663 |
| Fax |
|
| Email |
jilma@kozhnosys.com |
|
Details of Contact Person
Public Query
|
| Name |
Jilma Peruvangat |
| Designation |
Director |
| Affiliation |
Kozhnosys Pvt. Ltd. |
| Address |
Survey No. 38/2, 38/3, 56:57, Flat No. 803 Building- A,
15 XRBIA, Hinjewadi, Nr Datt, Pune-411215
Kozhnosys Pvt Ltd,
100, NCL Innovation Park, Pashan, Pune, 411008
Pune
MAHARASHTRA
411215
India |
| Phone |
9657782663 |
| Fax |
|
| Email |
jilma@kozhnosys.com |
|
|
Source of Monetary or Material Support
|
| Kozhnosys Pvt. Ltd., Registered office at Survey No. 38/2, 38/3, 56:57, Flat No. 803 Building- A,
15 XRBIA, Hinjewadi, Nr Datt, Pune-411215 |
|
|
Primary Sponsor
|
| Name |
Jilma Peruvanagt |
| Address |
Survey No. 38/2, 38/3, 56:57, Flat No. 803 Building- A,
15 XRBIA, Hinjewadi, Nr Datt, Pune-411215
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rushikesh Shinde |
Krsnaa Diagnostic Center, Sutar Hospital |
Diagnostic Center (Pathology & Imaging services), Ground floor, Shastri Nagar Road, Azad Nagar, Kothrud, Pune-411038
Pune
MAHARASHTRA |
8668860549
rushikesh15088@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee -Onco Life Cancer Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
1. Women undergoing mammography/Sono-Mammography in the diagnostic lab collaborator of Kozhnosys.
2. Women with confirmed breast cancer by biopsy report/FNAC/Histopathology. |
|
| ExclusionCriteria |
| Details |
1. Patients undergoing breast cancer treatment.
2. Pregnant & lactating mothers.
3. Previous history of treated breast cancer or cancer of any other site.
4. History of alcohol or any type of tobacco consumption.
5. A person with breathing difficulties or respiratory illness cannot provide an adequate breath sample.
6. 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 |
a. Screening Accuracy: To evaluate the screening accuracy of Kozhnosys’ CanScan Breath Analyzer in all-stage breast cancer by comparing its results with standard screening methods.
b. Screening Performance: To assess the sensitivity, specificity, positive predictive value, and negative predictive value of the CanScan Breath Analyzer in screening breast cancer.
|
26 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Cost-Effectiveness Analysis- To compare the cost-effectiveness of the CanScan Breath analyzer with traditional breast cancer screening methods.
b. Breath test Acceptability: To evaluate the acceptability and ease of using the CanScan Breath Analyzer among subjects.
c. Operational Feasibility: To determine the feasibility of integrating the CanScan Breath Analyzer into routine clinical practice for breast cancer screening.
|
26 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)
|
27/02/2026 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
This diagnostic accuracy study will evaluate the clinical performance of the CanScan Breath Analyzer for breast cancer screening. CanScan is a novel non-invasive device that detects volatile organic compounds in exhaled breath associated with breast cancer metabolism. The study will compare CanScan results with standard diagnostic methods including mammography, sono mammography, and biopsy to assess sensitivity, specificity, positive predictive value, and negative predictive value. Approximately 200 women will be enrolled, including 100 with newly diagnosed breast cancer and 100 controls with negative mammography findings. |