UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023606 |
|---|---|
| Receipt number | R000027182 |
| Scientific Title | Evaluation of risk-reducing salpingo-oophorectomy for patients with BRCA 1/2 mutation |
| Date of disclosure of the study information | 2016/08/12 |
| Last modified on | 2021/08/16 12:54:17 |
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Basic information
Public title
Evaluation of risk-reducing salpingo-oophorectomy for patients with BRCA 1/2 mutation
Acronym
Evaluation of RRSO for patients with BRCA 1/2 mutation
Scientific Title
Evaluation of risk-reducing salpingo-oophorectomy for patients with BRCA 1/2 mutation
Scientific Title:Acronym
Evaluation of RRSO for patients with BRCA 1/2 mutation
Region
| Japan |
Condition
Condition
hereditary breast and ovarian cancer: HBOC
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
establish system of RRSO
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)safety of RRSO
2)5year overall survival
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 salpingo-oophorectomy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
patients with deleterious familial mutation of BRCA 1/2
Key exclusion criteria
no mutation of BRCA1/2
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Noriomi |
| Middle name | |
| Last name | Matsumura |
Organization
Kindai University Hospital
Division name
Obstetrics and Gynecology
Zip code
589-8511
Address
377-1 Onohigashi Osakasayama Osaka Japan
TEL
072-366-0221
sanfu@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Hidekatsu |
| Middle name | |
| Last name | Nakai |
Organization
Kindai University Hospital
Division name
Obstetrics and gynecology
Zip code
589-8511
Address
377-1 Onohigashi Osakasayama Osaka Japan
TEL
072-366-0221
Homepage URL
sanfu@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kindai University Hospital
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
Ethics Committee, Kindai University Faculty of Medicine
Address
377-1 Onohigashi Osakasayama Osaka Japan
Tel
072-366-0221
zizen@med.kindai.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
| 2016 | Year | 08 | Month | 12 | 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
0
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
| 2016 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 12 | Day |
Last modified on
| 2021 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027182
