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Accuracy of the CanScan Breath test in people with newly Diagnosed Non-Breast Cancers.

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. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/099573
Enrollment
82
Registered
2025-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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: Breath analysis with CanScan Breath Analyzer (Screening device): Breath analysis using CanScan Breath Analyzer (Screening device). Procedure: Participants will b
duration 5-10 minutes. Intervention4: Nil: Nil Control Intervention1: NIL: NIL

Sponsors

Jilma Peruvanagt
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
False Positive Rate (FPR): Defined as the proportion of patients with non-breast cancers who receive a positive CanScan result, erroneously indicating breast cancer.Timepoint: 26 Weeks—

Secondary

MeasureTime frame
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. 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: Feb 4, 2026