UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027999 |
|---|---|
| Receipt number | R000031743 |
| Scientific Title | Risk reducing salpingo-oophorectomy RRSO in BRCA1/2 mutation carriers. |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2018/07/02 18:54:06 |
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Basic information
Public title
Risk reducing salpingo-oophorectomy RRSO in BRCA1/2 mutation carriers.
Acronym
Risk reducing salpingo-oophorectomy RRSO in BRCA1/2 mutation carriers.
Scientific Title
Risk reducing salpingo-oophorectomy RRSO in BRCA1/2 mutation carriers.
Scientific Title:Acronym
Risk reducing salpingo-oophorectomy RRSO in BRCA1/2 mutation carriers.
Region
| Japan |
Condition
Condition
Hereditary Breast and Ovarian Cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Women with a BRCA1/2 mutation or members of a hereditary breast ovarian cancer family (HBOC) have an increased risk of developing ovarian cancer. The only effective strategy to reduce this risk is a risk reducing salpingo-oophorectomy (RRSO). The aim of this study was to evaluate the short-term surgical outcome and safety of a RRSO.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The main outcome measure is the complication rate at 4 to 6 days and at 5 weeks after surgery, as indicator of safety of the surgical procedure.
Key secondary outcomes
Secondary outcomes are to evaluate the appearance of menopausal symptoms rate before the surgery and at 6 and 24 months after the surgery
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
| 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
Having a deleterious mutation of BRCA1/2 germline gene
Key exclusion criteria
Female has active invasive cancer.
Female with mental disabilities and who has difficulty to make a determination of therapy.
Female during pregnancy and lactation.
Femele with active infectional disease.
Female who a doctor consider inappropriate
Female under 20 years old
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kikkawa Fumitaka |
Organization
Nagoya university faculty of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
65, Tsurumacho, Showa ku, Nagoya city, Aichi, Japan
TEL
052-744-2261
kikkawaf@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Utsumi Fumi |
Organization
Nagoya university faculty of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
65, Tsurumacho, Showa ku, Nagoya city, Aichi, Japan
TEL
052-744-2261
Homepage URL
fufumifu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya university faculty of Medicine
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
| 2017 | Year | 09 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | 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
| 2017 | Year | 06 | Month | 29 | Day |
Last modified on
| 2018 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031743
