UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023187 |
|---|---|
| Receipt number | R000026730 |
| Scientific Title | Study on the effect of Risk-Reducing Salpingo-oophorectomy in hereditary breast and ovarian cancer |
| Date of disclosure of the study information | 2016/07/19 |
| Last modified on | 2025/01/20 21:33:22 |
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Basic information
Public title
Study on the effect of Risk-Reducing Salpingo-oophorectomy in hereditary breast and ovarian cancer
Acronym
Risk-reducing Salpingo-oophorectomy in BRCA1 or BRCA2 mutation carriers
Scientific Title
Study on the effect of Risk-Reducing Salpingo-oophorectomy in hereditary breast and ovarian cancer
Scientific Title:Acronym
Risk-reducing Salpingo-oophorectomy in BRCA1 or BRCA2 mutation carriers
Region
| Japan |
Condition
Condition
Hereditary breast and ovarian caccer
Classification by specialty
| Surgery in general | Breast surgery | 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
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Preventing treatment of the 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
surgical treatment (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
| 80 | years-old | >= |
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 | Yuuko |
| Middle name | |
| Last name | Yokohama |
Organization
Asahikawa medical university
Division name
Department of Gynecology
Zip code
0788510
Address
Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL
0166-68-2562
yukoy@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuuko |
| Middle name | |
| Last name | Yokohama |
Organization
Asahikawa Medical University
Division name
Department of Gynecology
Zip code
0788510
Address
Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL
0166-68-2562
Homepage URL
yukoy@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
Asahikawa Medical Univercity IRB
Address
Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
Tel
0166-65-2111
rs-kk.g@asahikawa-med.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
旭川医科大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2030 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 15 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026730
