UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029303 |
|---|---|
| Receipt number | R000033499 |
| Scientific Title | Feasibility study of risk reducing mastectomy for women with BRCA1/2 mutations. |
| Date of disclosure of the study information | 2017/09/27 |
| Last modified on | 2022/04/02 12:05:33 |
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Basic information
Public title
Feasibility study of risk reducing mastectomy for women with BRCA1/2 mutations.
Acronym
Feasibility study of risk reducing mastectomy for women with BRCA1/2 mutations.
Scientific Title
Feasibility study of risk reducing mastectomy for women with BRCA1/2 mutations.
Scientific Title:Acronym
Feasibility study of risk reducing mastectomy for women with BRCA1/2 mutations.
Region
| Japan |
Condition
Condition
Hereditary Breast and Ovarian Cancer
Classification by specialty
| Breast surgery | Obstetrics and Gynecology | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To confirm the safety and to assess the feasibility of Risk Reducing Mastectomy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Adverse events within 1 year aftr surgery
Key secondary outcomes
the rate of occult cancer
the rate of locoregional recurrence
Adverse events within 5 year aftr surgery
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
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
| Not applicable |
Gender
Female
Key inclusion criteria
females 20 years or older
after receiving genetic counseling in our institution
with BRCA1 or 2 mutation
without recurrence and distant metastasis
desire for risk reducing mastectomy
ECOG performance status 0
Key exclusion criteria
with other active primary cancer
inappropriate mental condition
pregnant or nursing
severe infection
physician judged in appropriateness
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akiyo |
| Middle name | |
| Last name | Yoshimura |
Organization
Aichi Cancer Center Hospital, Nagoya, Japan
Division name
Department of Breast Oncology
Zip code
4648681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL
052-762-6111
akiyo@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Akiyo |
| Middle name | |
| Last name | Yoshimura |
Organization
Aichi Cancer Center Hospital, Nagoya, Japan
Division name
Department of Breast Oncology
Zip code
4648681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL
052-762-6111
Homepage URL
akiyo@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital, Nagoya, Japan
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital, Nagoya, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center Hospital
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
Tel
052-762-6111
irb@aichi-cc.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 21 | 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 | 27 | Day |
Last modified on
| 2022 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033499
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
