UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033751 |
|---|---|
| Receipt number | R000038496 |
| Scientific Title | Procedure of risk rducing surgery for hereditary gynecologic tumor |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2020/03/20 21:00:43 |
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Basic information
Public title
Procedure of risk rducing surgery for hereditary gynecologic tumor
Acronym
RRSO
Scientific Title
Procedure of risk rducing surgery for hereditary gynecologic tumor
Scientific Title:Acronym
RRSO
Region
| Japan |
Condition
Condition
BRCA1, BRCA2,MLH1,MSH2,MSH6,PMS2,BRIP1,RAD51C or RAD51D mutation carriers
Classification by specialty
| Hematology and clinical oncology | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Critical prevention of ovarian, fallopian tubal and peritoneal cancer in hereditary tumor-related gene carrires by RRSO
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of ovarian, fallopian tubal and peritoneal cancer
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
| 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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
BRCA1, BRCA2,MLH1,MSH2,MSH6,PMS2,BRIP1,RAD51C or RAD51D mutation carrier
Key exclusion criteria
Woman affected a gynecology cancer
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Watanabe Takafumi |
Organization
Fukushima Medical University
Division name
Obstetrics and Gynecology
Zip code
Address
1 Hikariga-oka, Fukushima City 960-1295, JAPAN
TEL
024-547-1290
t-wata@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Watanabe Takafumi |
Organization
Fukushima Medical University
Division name
Obstetrics and Gynecology
Zip code
Address
1 Hikariga-oka, Fukushima City 960-1295, JAPAN
TEL
024-547-1290
Homepage URL
t-wata@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 10 | 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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | 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 | 08 | Month | 14 | Day |
Last modified on
| 2020 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038496
