UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035362 |
|---|---|
| Receipt number | 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 16:48:55 |
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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
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
sakashi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University hospital
breast surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040290
