UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025823 |
|---|---|
| Receipt number | R000029696 |
| Scientific Title | Risk-reducing salpingo-oohorectomy for hereditary breast and ovarian syndrome |
| Date of disclosure of the study information | 2017/01/24 |
| Last modified on | 2023/02/01 19:14:08 |
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Basic information
Public title
Risk-reducing salpingo-oohorectomy for hereditary breast and ovarian syndrome
Acronym
RRSO for HBOC
Scientific Title
Risk-reducing salpingo-oohorectomy for hereditary breast and ovarian syndrome
Scientific Title:Acronym
RRSO for HBOC
Region
| Japan |
Condition
Condition
Hereditary breast and ovarian caccer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The Preventing treatment of the ovarian cancer in BRCA1 and BRCA2 mutation carriers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The Preventing treatment of he ovarian cancer high risk case (BRCA1 and BRCA2 mutation carrier)
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
| Other |
Interventions/Control_1
abdominal or laparoscopic bilateral salpingo-oohorectomy
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
| 35 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
BRCA1 and BRCA2 mutation carrier
Key exclusion criteria
BRCA1 and BRCA2 gene mutation negative case
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kana |
| Middle name | |
| Last name | Iwai |
Organization
Nara Medical University
Division name
Gynecology and Obstetrics
Zip code
6348521
Address
840, Shijo-Cho, Kashihara City 6348521 Nara Japan
TEL
0744223051
iwaikana@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Iwai |
Organization
Nara Medical University
Division name
Gynecology and Obstetrics
Zip code
634-8521
Address
840, Shijo-Cho, Kashihara City 6348521 Nara Japan
TEL
0744223051
Homepage URL
iwaikana@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Nara Medical University
Address
840, Shijo-Cho, Kashihara City 6348521 Nara Japan
Tel
0744-22-3051
iwaikana@naramed-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
奈良県立医科大学（奈良）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 24 | 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
Date of protocol fixation
| 2014 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 24 | Day |
Last modified on
| 2023 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029696
