UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005292 |
|---|---|
| Receipt number | R000006184 |
| Scientific Title | Study on risk reducing salpingo-oophorectomy(RRSO) for BRCA1/2 mutation carriers |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2023/10/07 21:19:15 |
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Basic information
Public title
Study on risk reducing salpingo-oophorectomy(RRSO) for BRCA1/2 mutation carriers
Acronym
Study on RRSO for BRCA1/2 mutation carriers
Scientific Title
Study on risk reducing salpingo-oophorectomy(RRSO) for BRCA1/2 mutation carriers
Scientific Title:Acronym
Study on RRSO for BRCA1/2 mutation carriers
Region
| Japan |
Condition
Condition
hereditary breast and ovarian cancer
Classification by specialty
| Breast surgery | Obstetrics and Gynecology | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Feasibility and efficacy of risk reducing bilateral salpingo-oophorectomy are confirmed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
safety and outcome of risk reducing bilateral salpingo-oophorectomy
Key secondary outcomes
actual medical fee for RRSO
pathological findings of resested specimen for PBSO
satisfaction with PBSO
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. BRCA1/2 mutation carrier
2. the subjects understand and consent to problesms on pregnancy, childbirth and so on.
Key exclusion criteria
1.She desires having babies.
2.The case in which IRB doesn't approve to perform PBSO.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka |
| Middle name | |
| Last name | Nomura |
Organization
Cancer Institute Hospital
Division name
Gynecology
Zip code
1358550
Address
3-8-31, Ariake, koto-ku, Tokyo
TEL
03-3520-0111
hidetaka.nomura@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Hidetaka |
| Middle name | |
| Last name | Nomura |
Organization
Cancer Institute Hospital
Division name
Gynecology
Zip code
1358550
Address
3-8-31, Ariake, koto-ku, Tokyo
TEL
03-3520-0111
Homepage URL
hidetaka.nomura@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital
Department of Gynecology, Breast center,
Clinical Genetic Oncology
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
cancer Institute Hospital
Address
3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan
Tel
03-3520-0111
tiken@ml.jfcr.or.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
がん研有明病院（東京都）
Japanese Foundation for Cancer Research, Cancer Institute Hospital(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Safety and efficacy of RRSO is examined in this observational study.
Total medical fee on RRSO will be clarified.
Resected specimen will be carefully observed pathologically.
Management information
Registered date
| 2011 | Year | 03 | Month | 23 | Day |
Last modified on
| 2023 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006184
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/05/17 | 2010-1101_予防的卵巣卵管切除＿臨床試験研究計画書_2022.4.25.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
