| CTRI Number |
CTRI/2025/12/099573 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Accuracy of the CanScan Breath test in people with newly Diagnosed Non-Breast Cancers. |
|
Scientific Title of Study
|
Clinical Investigation Plan to evaluate the false positive detection rate of the CanScan Breath Analyzer in patients newly diagnosed with cancers other than breast cancer. |
| 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 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 |
Kozhnosys Pvt Ltd,
100, NCL Innovation Park, Pashan, Pune, 411008
Registered office at Survey No. 38/2, 38/3, 56:57, Flat no. 803 Building- A, 15 XRBIA, Hinjewadi, Nr Datt, Pune-411215
Pune
MAHARASHTRA
411008
India |
| Phone |
9657782663 |
| Fax |
|
| Email |
jilma@kozhnosys.com |
|
Details of Contact Person
Public Query
|
| Name |
Jilma Peruvangat |
| Designation |
Director |
| Affiliation |
Kozhnosys Pvt. Ltd. |
| Address |
Kozhnosys Pvt Ltd,
100, NCL Innovation Park, Pashan, Pune, 411008
Registered office at Survey No. 38/2, 38/3, 56:57, Flat no. 803 Building- A, 15 XRBIA, Hinjewadi, Nr Datt, Pune-411215
Pune
MAHARASHTRA
411008
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 |
Registered office at 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 |
| Dr Gaurav Jaswal |
TGH Onco-life Cancer Center, General Hospital Campus |
TGH Onco-life Cancer Center,
General Hospital Campus,
Talegaon Chakan Road, Talegaon Dabhade-410506
Pune
MAHARASHTRA |
7009521950
gaurav.jaswal@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 |
CanScan Breath Analyzer for Breast Cancer Screening |
Intervention: Breath analysis using CanScan Breath Analyzer (Screening device). Procedure: Participants will be asked to provide a breath sample into the CanScan device. The analyzer will process the sample and generate a diagnostic output. Purpose: To evaluate the ability of the CanScan Breath Analyzer to detect breast cancer. Duration-CanScan Breath Analyzer - single breath test performed once per participant; duration 5-10 minutes. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Adults aged 18 years and above.
2) Male and female participants.
3) Adults with a newly diagnosed and confirmed cancer.
4) Able to provide informed consent.
5) Willing and able to undergo breath sample collection.
|
|
| ExclusionCriteria |
| Details |
1) History of breast cancer (past or present).
2) Presence of severe respiratory illness or conditions affecting breath sample quality (e.g., COPD, active tuberculosis).
3) Already undergoing cancer treatment.
4) Undergone surgery for cancer tumor removal.
5) Undergoing chemo/radiation therapy for cancer treatment.
6) Pregnant & lactating mothers.
7) Inability to comply with study procedures.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| False Positive Rate (FPR): Defined as the proportion of patients with non-breast cancers who receive a positive CanScan result, erroneously indicating breast cancer. |
26 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the false positive detection performance of the CanScan Breath Analyzer in a cohort of patients newly diagnosed with cancers other than breast cancer, by:
a. Assessing the specificity of CanScan’s volatile organic compound (VOC) profiling algorithm across a
heterogeneous group of malignancies.
b. Identifying potential cross-reactivity patterns or VOC overlaps that may contribute to false positive results.
|
26 Weeks |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
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 single center observational study will evaluate the false positive detection rate of the CanScan Breath Analyzer in adult patients newly diagnosed with cancers other than breast cancer. The CanScan device, previously validated for breast cancer detection, uses volatile organic compound profiling to identify cancer-related metabolic signatures in exhaled breath. The study will assess diagnostic specificity by comparing CanScan results with confirmed clinical diagnoses obtained through standard procedures such as biopsy, imaging, cytology, and histopathology. Approximately 82 participants will be enrolled to represent diverse cancer types and demographic backgrounds. Findings will inform refinement of the CanScan algorithm and improve its accuracy for breast cancer detection by reducing misclassification risk. |