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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024515
Receipt No. 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 2019/04/24

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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
Obsterics 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 Takuma
Middle name
Last name Fujii
Organization Fujita Health University
Division name Gynecology and Obstetrics
Zip code 470-1192
Address 1-98 Dengakugakubo Kutsukake Toyoake Aichi
TEL 0562939294
Email ryoko_jjj@yahoo.co.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
Email research@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University, Gynecology and Obstetrics
Institute
Department

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
Email 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
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026589

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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