| CTRI Number |
CTRI/2025/04/084786 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study compared the CanScan device for analyzing breath markers in breast cancer patients and healthy women, both fasting and not fasting. |
|
Scientific Title of Study
|
An open-label, comparative crossover study of CanScan medical device for volatile marker analysis in exhaled breath of breast cancer patients and healthy women under fasting and non-fasting conditions. |
| 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 Jaiswal |
| Designation |
Director Oncology |
| Affiliation |
TGH Onco-life Cancer Center |
| Address |
TGH Onco-life Cancer Center, General Hospital campus, Talegaon Chakan road, Talegaon Dabhade, 410506
Pune
MAHARASHTRA
410506
India |
| Phone |
7009521950 |
| Fax |
|
| Email |
drjaiswal.alphapluscrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jilma Peruvangat |
| Designation |
Director |
| Affiliation |
Kozhnosys. Pvt. Ltd |
| Address |
803, A-15, Xrbia Hinjewadi,
Nere Dattawadi, Pune-412115
Pune
MAHARASHTRA
412115
India |
| Phone |
9833482033 |
| Fax |
|
| Email |
jilma@kozhnosys.com |
|
Details of Contact Person
Public Query
|
| Name |
Jilma Peruvangat |
| Designation |
Director |
| Affiliation |
Kozhnosys. Pvt. Ltd |
| Address |
803, A-15, Xrbia Hinjewadi,
Nere Dattawadi, Pune-412115
MAHARASHTRA
412115
India |
| Phone |
9833482033 |
| Fax |
|
| Email |
jilma@kozhnosys.com |
|
|
Source of Monetary or Material Support
|
| Start-Up
Kozhnosys Pvt. Ltd.
803, A-15, Xrbia Hinjewadi, Nere Dattawadi,
Pune MAHARASHTRA 412115
India Pune MAHARASHTRA 412115 India |
|
|
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
|
|
|
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 Jaiswal |
TGH Onco-life Cancer Center |
General Hospital campus, Talegaon Chakan road, Talegaon Dabhade, 410506
Pune
MAHARASHTRA |
7009521950
drjaiswal.alphapluscrs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kusum Independent Ethics Committee |
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 |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1)Willing to fill out the informed consent form.
2)Female in the age group 30 to 80 years with or without common medical conditions like Hypertension, Hyperlipidaemia, Hypothyroidism, Arthritis, Asthma, GERD, Diabetes, PCOD, Vitamin D deficiency, Calcium Deficiency, Iron deficiency, Menopause etc.
3)Confirmed cases of breast cancer (positive mammography) but not exposed to any previous treatment cycle or surgery.
4)If CanScans result is positive, but negative mammography reports the patient should agree to do an MRI to verify a false positive or false negative result.
5)If CanScans result is negative but positive mammography reports the patient should agree to do an MRI to verify a false positive or false negative result.
6)Willing to undertake a routine mammography test.
7)Women with positive mammograms should share the biopsy report after breast cancer confirmation or non-confirmation. |
|
| ExclusionCriteria |
| Details |
1)Age group below 30 years.
2)Already undergoing cancer treatment.
3)Undergone surgery for breast tumor removal.
4)The patient is not ready for an MRI after a negative mammography report and a positive CanScan result.
5)The patient is not ready for an MRI after a positive mammography report and a negative CanScan result.
6)The patient is not sharing the biopsy report.
7)Excluding pregnant participants.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CanScan accuracy (sensitivity, specificity) for breast cancer patients vs. healthy subjects. |
16 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VOC (Volatile organic compounds) profile in
cancer: Detection of biomarkers using Canscan.
1.- Differentiation breath VOCs in cancer &
healthy volunteers.
2.-Canscan sensitivity & Specificity. |
16 Weeks |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
01/09/2025 |
| 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="4"
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 comparative crossover study of the CanScan device for volatile marker analysis in exhaled breath of breast cancer patients (Mammography Positive) and healthy women (Mammography negative). VOCs detected with specific sensors and the sensitivity and specificity of the CanScan would be assessed. The study will be able to differentiate between VOC of cancer and non-cancer patients. The study will be conducted on 60 mammogram-positive women and 50 mammogram-negative women fulfilling the inclusion and exclusion criteria.
|