UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024243
Receipt No. R000027916
Scientific Title Prospective study on the safety of risk-reducing surgery for gynecological cancer of Hereditary breast ovarian cancer syndrome (HBOC) patient
Date of disclosure of the study information 2016/10/01
Last modified on 2019/04/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective study on the safety of risk-reducing surgery for gynecological cancer of Hereditary breast ovarian cancer syndrome (HBOC) patient
Acronym RRSO study
Scientific Title Prospective study on the safety of risk-reducing surgery for gynecological cancer of Hereditary breast ovarian cancer syndrome (HBOC) patient
Scientific Title:Acronym RRSO study
Region
Japan

Condition
Condition Hereditary breast ovarian cancer syndrome; HBOC
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 safety of the risk reducung surgery
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse event
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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Risk reducing surgery
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 Having a deleterious mutation of BRCA1/2 germline gene
Key exclusion criteria BRCA
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Ryutaro
Middle name
Last name Nishikawa
Organization Nagoya city university
Division name Obstetrics and gynecology
Zip code 467-8602
Address Kawasumi1, Mizuho-cho, Mizuho-ku, Nagoya-city , Aichi pre. Japan
TEL 052-853-8241
Email ryu0717@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Ryutaro
Middle name
Last name Nishikawa
Organization Nagoya city university
Division name Obstetrics and gynecology
Zip code 467-8602
Address Kawasumi1, Mizuho-cho, Mizuho-ku, Nagoya-city, Aichi-pre. Japan
TEL 052-853-8241
Homepage URL
Email ryu0717@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya city university
Institute
Department

Funding Source
Organization Nagoya city university
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya city university
Address Kawasumi1, Mizuho-cho, Mizuho-ku,Nagoya-city
Tel 052-851-5511
Email ryu0717@med.nagoya-cu.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

Other administrative information
Date of disclosure of the study information
2016 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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 30 Day
Date of IRB
2016 Year 09 Month 30 Day
Anticipated trial start date
2016 Year 09 Month 30 Day
Last follow-up date
2021 Year 09 Month 30 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 09 Month 30 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027916

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.