UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033384 |
|---|---|
| Receipt number | R000038011 |
| Scientific Title | Feasibility study of risk reducing salpingo-oophorectomy for BRCA1/2 mutation carrier |
| Date of disclosure of the study information | 2018/07/17 |
| Last modified on | 2025/01/16 19:51:08 |
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Basic information
Public title
Feasibility study of risk reducing salpingo-oophorectomy for BRCA1/2 mutation carrier
Acronym
RRSO for BRCA1/2 mutation carrier
Scientific Title
Feasibility study of risk reducing salpingo-oophorectomy for BRCA1/2 mutation carrier
Scientific Title:Acronym
RRSO for BRCA1/2 mutation carrier
Region
| Japan |
Condition
Condition
Hereditary breast ovarian cancer syndrome
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the feasibility of risk reducing salpingo-oophorectomy for BRCA mutation carrier
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of adverse event intra- or after operation
Key secondary outcomes
Rate of operation associated death
Incidence of of occult cancer
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
risk reducing sapling-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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.BRCA mutant carrier
2.no prior ovarian cancer
3.wish for operation after counseling
4.no wish for pregnancy
5.over 35 years old
Key exclusion criteria
no mutation of BRCA
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Norihiro |
| Middle name | |
| Last name | Sugino |
Organization
Yamaguchi University
Division name
Obstetrics and Gynecology
Zip code
755-8505
Address
1-1-1 Minami-kogushi Ube, Japan
TEL
0836-22-2288
obgyn@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Sueoka |
Organization
Yamaguchi University
Division name
Obstetrics and Gynecology
Zip code
755-8505
Address
1-1-1 Minami-kogushi Ube, Japan
TEL
0836-22-2288
Homepage URL
obgyn@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi 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
IRB Yamaguchi university hospital
Address
1-1-1 Minami-kogushi Ube, Japan
Tel
0836-22-2428
me223@yamaguchi-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
山口大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 17 | 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
| 2018 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | 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 | 07 | Month | 13 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038011
