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Evaluation of the CanScan Breath Test for Screening Breast Cancer in Women.

Clinical performance evaluation of the CanScan breath analyzer for breast cancer screening. - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/099452
Enrollment
200
Registered
2025-12-19
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 Intervention2: CanScan Breath Analyzer for Breast Cancer Screening: Intervention: Breath Analyzer for Breast Cancer Screening. Procedure: Participants will be asked to provide
duration 5-10 minutes. Intervention3: Nil: Nil Intervention4: Nil: Nil Control Intervention1: Mammography: Comparator: Mammography (standard screening method for breast cancer). Procedure: All partic

Sponsors

Jilma Peruvanagt
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women undergoing mammography/Sono-Mammography in the diagnostic lab collaborator of Kozhnosys. 2. Women with confirmed breast cancer by biopsy report/FNAC/Histopathology.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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. Timepoint: 26 weeks—

Secondary

MeasureTime frame
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. Timepoint: 26 Weeks—

Countries

India

Contacts

Public ContactJilma Peruvangat

Kozhnosys Pvt. Ltd.

jilma@kozhnosys.com9657782663

Outcome results

None listed

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