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A study compared the CanScan device for analyzing breath markers in breast cancer patients and healthy women, both fasting and not fasting.

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. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/084786
Enrollment
110
Registered
2025-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Kozhnosys Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
CanScan accuracy (sensitivity, specificity) for breast cancer patients vs. healthy subjects.Timepoint: 16 Weeks

Secondary

MeasureTime frame
VOC (Volatile organic compounds) profile in cancer: Detection of biomarkers using Canscan. 1.- Differentiation breath VOCs in cancer & healthy volunteers. 2.-Canscan sensitivity & Specificity.Timepoint: 16 Weeks

Countries

India

Contacts

Public ContactJilma Peruvangat

Kozhnosys. Pvt. Ltd

jilma@kozhnosys.com9833482033

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026