UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015021 |
|---|---|
| Receipt number | R000017473 |
| Scientific Title | Safety and efficacy study of Risk-Reducing salpingo-oopholectomy in BRCA1/2 mutant carriers |
| Date of disclosure of the study information | 2014/09/30 |
| Last modified on | 2016/06/20 08:38:16 |
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Basic information
Public title
Safety and efficacy study of Risk-Reducing salpingo-oopholectomy in BRCA1/2 mutant carriers
Acronym
Cohort Study of Risk Reducing Salpingo-oophlectomy in HBOC
Scientific Title
Safety and efficacy study of Risk-Reducing salpingo-oopholectomy in BRCA1/2 mutant carriers
Scientific Title:Acronym
Cohort Study of Risk Reducing Salpingo-oophlectomy in HBOC
Region
| Japan |
Condition
Condition
Hereditary Breast and Ovarian Cancer syndrome: HBOC
Classification by specialty
| Surgery in general | Endocrine surgery | Breast surgery |
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of risk reducing salpingo-oophorectomy (RRSO) in BRCA1/2 mutnat carriers
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event related to RRSO
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: RRSO
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. BRCA1/2 mutant carriers
2. Tolerability to RRSO
3. informed consent
Key exclusion criteria
1. Women with tubular or ovarian disease
2. physicians decision
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichiro Nakamura |
Organization
Okayama university hospital
Division name
Department of gynecology
Zip code
Address
Shikata-cho 2-5-1, Okayama-city
TEL
086-235-7636
k-nakamu@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naruto Taira |
Organization
Okayama University Hospital
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
Shikata-cho 2-5-1, Okayama-city
TEL
086-235-7265
Homepage URL
ntaira@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama university hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama 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
Address
Tel
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
| 2014 | Year | 09 | Month | 30 | 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
| 2016 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | 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
| 2014 | Year | 09 | Month | 02 | Day |
Last modified on
| 2016 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017473
