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A Multicenter Prospective Exploratory Study to Evaluate the Performance of Devices for Detecting Volatile Organic Compounds in Exhaled Breath for Breast Cancer Screening

A Multicenter Prospective Exploratory Study to Evaluate the Performance of Devices for Detecting Volatile Organic Compounds in Exhaled Breath for Breast Cancer Screening - A Multicenter Prospective Exploratory Study to Evaluate the Performance of Devices for Detecting Volatile Organic Compounds in Exhaled Breath for Breast Cancer Screening

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1030260203
Enrollment
1000
Registered
2026-06-08
Start date
2025-01-28
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Breast Neoplasms

Interventions

None listed

Sponsors

Akashi Sadako
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Eligibility is limited to patients who meet both of the following criteria: 1.Female patients diagnosed with primary breast cancer prior to the start of treatment 2.Patients who have provided informed consent to participate in this trial Eligibility is limited to those who meet either criteria 1 and 3 or criteria 2 and 3 below. 1.Women who visited a clinic for breast cancer screening 2.Female patients who were informed of a possible breast cancer diagnosis and visited a clinic for further evaluation 3.Patients who have provided informed consent to participate in this trial

Exclusion criteria

Exclusion criteria: 1.Patients under the age of 18 2.Patients with a history of breast cancer treatment prior to enrollment in this trial 3.Patients in whom a needle biopsy cannot be performed 4.Patients currently taking oral hypoglycemic agents (metformin hydrochloride) 5.Other patients deemed unsuitable for inclusion in the study by the principal investigator

Design outcomes

Primary

MeasureTime frame
Sensitivity and Specificity of Breast Cancer Diagnosis Using Volatile Organic Compounds in Exhaled Breath

Secondary

MeasureTime frame
1.Positive predictive value (PPV) and negative predictive value (NPV) of volatile organic compounds in exhaled breath for breast cancer diagnosis 2.Correlation between volatile organic compounds in exhaled breath and histopathological diagnosis 3.Correlation between volatile organic compounds in exhaled breath and disease stage

Contacts

Public ContactHiroko Tsukada

Tokyo Women's Medical University Hospital

tsukada.hiroko@twmu.ac.jp+81-3-3353-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026