UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042457 |
|---|---|
| Receipt number | R000048467 |
| Scientific Title | Risk-reducing mastectomy and observational studies for cancer-free hereditary breast and ovarian cancer syndrome |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2023/11/20 11:31:02 |
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Basic information
Public title
Risk-reducing mastectomy and observational studies for cancer-free hereditary breast and ovarian cancer syndrome
Acronym
Risk-reducing mastectomy and observational studies for cancer-free hereditary breast and ovarian cancer syndrome
Scientific Title
Risk-reducing mastectomy and observational studies for cancer-free hereditary breast and ovarian cancer syndrome
Scientific Title:Acronym
Risk-reducing mastectomy and observational studies for cancer-free hereditary breast and ovarian cancer syndrome
Region
| Japan |
Condition
Condition
hereditary breast and ovarian cancer syndrome
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prevention of breast cancer by bilateral risk reducing mastectomy in cancer-free BRCA1 and 2 mutation carriers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prognosis
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
| Maneuver |
Interventions/Control_1
Bilateral risk reducing mastectomy
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
BRCA1 and 2 mutation carriers with breast and ovarian cancer-free cases who have received appropriate genetic counseling and have a good understanding of the disease and are willing to undergo bilateral risk reducing mastectomy.
Key exclusion criteria
A person who is judged by the principal investigator to be an inappropriate subject for this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsu |
| Middle name | |
| Last name | Hayashida |
Organization
Keio university
Division name
General and gastrointestinal surgery
Zip code
1608582
Address
35 Shinanomachi, Shinjyuku, Tokyo
TEL
0333531211
tetsu@keio.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Seki |
Organization
Keio university
Division name
General and gastrointestinal surgery
Zip code
1608582
Address
35 Shinanomachi, Shinjyuku, Tokyo
TEL
0333531211
Homepage URL
tomnabe@z2.keio.jp
Sponsor or person
Institute
Keio university
Institute
Department
Personal name
Funding Source
Organization
Keio university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio Universisty
Address
35 Shinanomachi, Shinjyuku, Tokyo
Tel
0333531211
keio@esct.bvits.com
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
| 2021 | Year | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 15 | Day |
Last modified on
| 2023 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048467
