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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035362
Receipt No. R000040290
Scientific Title Prospective exploratory diagnstic trial for evaluation of breast cancer detecting method by analyzing volatile organic compounds (VOCs) in exhaled air
Date of disclosure of the study information 2018/12/25
Last modified on 2020/06/30

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Basic information
Public title Prospective exploratory diagnstic trial for evaluation of breast cancer detecting method by analyzing volatile organic compounds (VOCs) in exhaled air
Acronym VOCs trial for detecting breast cancer
Scientific Title Prospective exploratory diagnstic trial for evaluation of breast cancer detecting method by analyzing volatile organic compounds (VOCs) in exhaled air
Scientific Title:Acronym VOCs trial for detecting breast cancer
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 identify VOC biomarker in exhaled air for detecting breast cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes sensitivity and specificity of breast cancer detection using VOC
Key secondary outcomes positive predictive value and negative predictive value

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 collecting exhaled air in the sampler
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
35 years-old <=
Age-upper limit
100 years-old >
Gender Female
Key inclusion criteria 1)woman with breast cancer before treatment or woman who wants to have breast screening

2)olader than 35 yo
3)obtained written informed consent
Key exclusion criteria 1) past history of breast cancer
2) past history of other malignancies
3) who can not be undergo breast biopsy
4) pregnant
5) diabetes mellitus
6) who are taking antihypercholestrolemia
Target sample size 670

Research contact person
Name of lead principal investigator
1st name Seigo
Middle name
Last name Nakamura
Organization Showa University hospital
Division name breast surgery
Zip code 142-8666
Address Hatanodai 1-5-8 Shinagawa-ku, Tokyo
TEL 03-3784-8000
Email seigonak@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Sadako
Middle name
Last name Akashi-Tanaka
Organization Showa University hospital
Division name breast surgery
Zip code 142-8666
Address Hatanodai 1-5-8 Shinagawa-ku, Tokyo
TEL 03-3784-8000
Homepage URL
Email sakashi@med.showa-u.ac.jp

Sponsor
Institute Showa University hospital
breast surgery
Institute
Department

Funding Source
Organization ecsola medical
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional review board
Address Hatanodai 1-5-8, Shinagawa-ku, Tokyo
Tel 03-3784-8000
Email m-rinri@ofc.showa-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 昭和大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 25 Day

Related information
URL releasing protocol none
Publication of results Unpublished

Result
URL related to results and publications none
Number of participants that the trial has enrolled 675
Results
not detected
Results date posted
2020 Year 06 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients who visited Showa University Hospital from May 2017 to September 2018
Participant flow
exhale air into a special vessel
Adverse events
none
Outcome measures
biomarker for distinguishing women with breast cancer or benign disease
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
2016 Year 08 Month 18 Day
Anticipated trial start date
2017 Year 05 Month 06 Day
Last follow-up date
2018 Year 09 Month 27 Day
Date of closure to data entry
2018 Year 09 Month 27 Day
Date trial data considered complete
2019 Year 06 Month 26 Day
Date analysis concluded
2019 Year 07 Month 02 Day

Other
Other related information

Management information
Registered date
2018 Year 12 Month 25 Day
Last modified on
2020 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040290

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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