UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024515 |
|---|---|
| Receipt number | R000026589 |
| Scientific Title | Establishment of risk-reducing salpingo-oohorectomy for hereditary breast and ovarian syndrome |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2024/10/27 11:51:11 |
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Basic information
Public title
Establishment of risk-reducing salpingo-oohorectomy for hereditary breast and ovarian syndrome
Acronym
Establishment RRSO for HBOC
Scientific Title
Establishment of risk-reducing salpingo-oohorectomy for hereditary breast and ovarian syndrome
Scientific Title:Acronym
Establishment RRSO for HBOC
Region
| Japan |
Condition
Condition
ovarian cancer
tubal cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
feasibility study of RRSO for HBOC syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
prognosis(OS, acquiring and recurrence of BRCA related cancer
Key secondary outcomes
menopausal problem
occult cancer
QOL of women after RRSO(EORTC QLQ-OV28)
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
| Device,equipment |
Interventions/Control_1
abdominal or laparoscopic bilateral salpingo-oohorectomy
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
Female above 20 years old with mutation of BRCA1/2
Female with no ovarian or tuben cancer.
Female with prior written consent for operation by voluntary agreement.
Female with ECOG PS(Eastern Cooperative Oncology Group Performance Status) 0-2.
Female in systemic good condition.
Key exclusion criteria
Female with mental disabilities and who has difficulty to make a determination of therapy.
Female has active invasive cancer (except for basal cell carcinoma and squamous cell carcinoma and carcinoma in situ).
Female during pregnancy and lactation.
Femele with following diseases (thrombotic and hemorrhagic disease, uncontrollable hypertension, unstable renal failure, unstable hepatic failure, unhealed wound, unhealed ulcer, and unhealed fracture).
Female who a doctor consider inappropriate
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Haruki |
| Middle name | |
| Last name | Nishizawa |
Organization
Fujita Health University
Division name
Gynecology and Obstetrics
Zip code
470-1192
Address
1-98 Dengakugakubo Kutsukake Toyoake Aichi
TEL
0562939294
ryokojjj@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Ikue |
| Middle name | |
| Last name | Tanikawa |
Organization
Fujita Health University
Division name
Center for Research Promotion and Support
Zip code
470-1192
Address
1-98 Dengakugakubo Kutsukake Toyoake Aichi
TEL
0562-93-2865
Homepage URL
research@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University, Gynecology and Obstetrics
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Center for Research Promotion and Support, Fujita Health University
Address
1-98 Dengakugakubo Kutsukake Toyoake Aichi
Tel
0562-93-2865
research@fujita-hu.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
藤田医科大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2016 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026589
