UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029145 |
|---|---|
| Receipt number | R000033326 |
| Scientific Title | Detectability of breast lesions of dense breast using low-dose computed tomography |
| Date of disclosure of the study information | 2017/09/14 |
| Last modified on | 2018/07/06 17:37:15 |
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Basic information
Public title
Detectability of breast lesions of dense breast using low-dose computed tomography
Acronym
Detectability of breast lesions of dense breast using low-dose computed tomography
Scientific Title
Detectability of breast lesions of dense breast using low-dose computed tomography
Scientific Title:Acronym
Detectability of breast lesions of dense breast using low-dose computed tomography
Region
| Japan |
Condition
Condition
Breast lesions
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether breast lesions of dense breast could be detected by low-dose computed tomography images.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detectability of breast lesions on low-dose computed tomography images.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
One low-dose chest computed tomography after breast cancer screening and assessment of that image.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients who are diagnosed with dense breast by mammography and recommended a detailed examination.
Patients who are diagnosed with breast lesion(s) by ultrasonography.
Key exclusion criteria
Patients who already had a lung cancer screening on the same day with breast cancer screening.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Takagi |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
Address
Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, JAPAN
TEL
011-706-2826
talltree@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Takagi |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
Address
Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, JAPAN
TEL
011-706-2826
Homepage URL
talltree@hs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
The Hitachi Global Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 14 | Day |
Last modified on
| 2018 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033326
