臨床研究等提出・公開システム

Date of registration	June. 08, 2026
Last modified on	June. 08, 2026
Trial ID	jRCT1030260203

Scientific Title	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)
Public Title	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)

Contact for Scientific Queries	Name	Akashi Sadako
	Affiliation	Tokyo Women's Medical University Hospital
	Address	8-1, Kawadacho, Shinjuku-ku, Tokyo, Japan
	Telephone	+81-3-3353-8111
	E-mail	akashi.sadako@twmu.ac.jp
Contact for Public Queries	Name	Tsukada Hiroko
	Affiliation	Tokyo Women's Medical University Hospital
	Address	8-1, Kawadacho, Shinjuku-ku, Tokyo, Japan
	Telephone	+81-3-3353-8111
	E-mail	tsukada.hiroko@twmu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 28, 2025
Actual date of first enrollment		Jan. 28, 2025
Target sample size		1000
Study Type		Observational
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	parallel assignment
	purpose	screening
Key inclusion & exclusion 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	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
	Age Minimum	18age 0month 0week old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		Breast Neoplasms
Health Condition(s) Code		Breast Neoplasms
Primary Outcome(s)		Sensitivity and Specificity of Breast Cancer Diagnosis Using Volatile Organic Compounds in Exhaled Breath
Secondary Outcome(s)		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

Primary Sponsor	MediScan Co., Ltd.

Source of Monetary Support / Secondary Sponsor	MediScan Co., Ltd.
Secondary Sponsor	Not applicable

Source of Monetary Support	MediScan Co., Ltd.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Ethics Review Committee, Tokyo Women's Medical University
Address	8-1Kawada-cho, Shinjuku, Tokyo, Tokyo
Telephone	+81-3-3353-8111
E-Mail	rinri.bm@twmu.ac.jp
Approval Status	Approval
Date of approval	Jan. 14, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none