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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.

Clinical Performance Evaluation of CanScan Breath Analyzer for Breast Cancer Screening. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/085190
Enrollment
200
Registered
2025-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Sponsors

Kozhnosys Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 32

Secondary

MeasureTime frame
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.Timepoint: 4 weeks

Countries

India

Contacts

Public ContactJilma Peruvangat

Kozhnosys Pvt. Ltd.

jilma@kozhnosys.com9833482033

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026