UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031858 |
|---|---|
| Receipt number | R000036379 |
| Scientific Title | Feasibility study of risk-reducing mastectomy for hereditary breast and ovarian cancer syndrome with BRCA1/2 mutation |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/09/23 18:49:19 |
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Basic information
Public title
Feasibility study of risk-reducing mastectomy for hereditary breast and ovarian cancer syndrome with BRCA1/2 mutation
Acronym
Feasibility study of risk-reducing mastectomy for BRCA1/2 mutation
Scientific Title
Feasibility study of risk-reducing mastectomy for hereditary breast and ovarian cancer syndrome with BRCA1/2 mutation
Scientific Title:Acronym
Feasibility study of risk-reducing mastectomy for BRCA1/2 mutation
Region
| Japan |
Condition
Condition
Hereditary Breast and Ovarian Cancer Syndrome
Classification by specialty
| Breast surgery | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the safety of risk-reducing mastectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of the adverse event during 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
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
1. Women with BRCA1/2 pathogenic mutation who desire risk-reducing mastectomy
2. No clinical evidence of malignancy in the breast
3. ECOG Performance Status 0-1
4. Without major organ disorder
5. Age >=20
6. Understanding that medical expenses of the risk-reducing mastectomy is not covered by insurance
7. Written informed consent
Key exclusion criteria
1. Patients with reccurent or metastatic breast cancer
2. Patients with other factors not eligible for this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Toi |
Organization
Kyoto University Hospital
Division name
Breast Surgery
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
toi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Takada |
Organization
Kyoto University Hospital
Division name
Breast Surgery
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
Homepage URL
masahiro@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida Konoe, Sakyo-ku, Kyoto, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2018 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 23 | Day |
Last modified on
| 2020 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036379
