UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021254 |
|---|---|
| Receipt number | R000024515 |
| Scientific Title | Study on risku reducing mastectomy for NRCA1/2 mutation carriers |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2019/03/03 10:00:06 |
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Basic information
Public title
Study on risku reducing mastectomy for NRCA1/2 mutation carriers
Acronym
Study on RRM for BRCA1/2 mutation carriers
Scientific Title
Study on risku reducing mastectomy for NRCA1/2 mutation carriers
Scientific Title:Acronym
Study on RRM for BRCA1/2 mutation carriers
Region
| Japan |
Condition
Condition
hereditary breast and ovarian cancer
Classification by specialty
| Breast surgery | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the safety of risk reducing mastectomy in BRCA1/2 mutant carriers
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Perioperative complications related to risk reducing mastectomy
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
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
| 35 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. BRCA1/2 mutant carriers
2. Informed consent
Key exclusion criteria
1. Women with bilateral breast cancer
2. Physician decision
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsu Hayashida |
Organization
Keio University School of medicine
Division name
Department of surgery
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
+81-3-3353-1211
tetsu@z7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | tetsu Hayashida |
Organization
Keio University School of medicine
Division name
Department of surgery
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
+81-3-3353-1211
Homepage URL
tetsu@z7.keio.jp
Sponsor or person
Institute
Keio University School of medicine
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
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
| 2016 | Year | 04 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 29 | Day |
Last modified on
| 2019 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024515
