UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028849 |
|---|---|
| Receipt number | R000033018 |
| Scientific Title | Feasibility study of Risk Reducing Mastectomy and Risk Reducing Salpingo-Oophorectomy for Hereditary Breast and Ovarian Cancer |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2020/09/01 15:29:15 |
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Basic information
Public title
Feasibility study of Risk Reducing Mastectomy and Risk Reducing Salpingo-Oophorectomy for Hereditary Breast and Ovarian Cancer
Acronym
Feasibility study of RRM and RRSO for HBOC
Scientific Title
Feasibility study of Risk Reducing Mastectomy and Risk Reducing Salpingo-Oophorectomy for Hereditary Breast and Ovarian Cancer
Scientific Title:Acronym
Feasibility study of RRM and RRSO for HBOC
Region
| Japan |
Condition
Condition
HBOC
Classification by specialty
| Breast surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Safety assessment of RRM and RRSO For HBOC
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1Safety of surgery 2Prognosis 3QOL after surgery 4Complication of surgery 5Pathological data
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Genetic testing has confirmed a mutation in BRCA 1/2, and the individual desires RRM/RRSO after genetic counseling.
2) It is desirable person who have children, or understand that fertility is lost after this treatment with Husband, or does not wish to have baby, or have willing RRSO priority than wish to have baby.
3) Fully understanding the symptoms after RRM/RRSO.
4) Fully understanding that RRM/RRSO is self-pay.
5) Fully understanding that RRM/RRSO is clinical trial.
6) The person who choose RRM/RRSO does not have malignacy of breast and ovary.
Key exclusion criteria
doctor's decision not to be registered to this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Fumio |
| Middle name | |
| Last name | Takada |
Organization
Kitasato University Hospital
Division name
Genetics
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa.
TEL
042-778-8111
ftakada@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Araki |
Organization
Kitasato University Hospital
Division name
Genetics
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa.
TEL
042-778-8111
Homepage URL
arnaoe@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitasato University Hospital, Gynecology
Kitasato University Hospital, Breast and Endocrine Surgery
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research and Treatment
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa.
Tel
042-778-8111
rinrib@med.kitasato-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
| 2017 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Safety assessment of RRM and RRSO For HBOC
Management information
Registered date
| 2017 | Year | 08 | Month | 27 | Day |
Last modified on
| 2020 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033018
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
