UMIN-CTR Clinical Trial

Basic information
Public title	risk-reducing surgery for pathogenic variant carriers of gynecologic hereditary tumors
Acronym	risk-reducing surgery for pathogenic variant carriers of gynecologic hereditary tumors
Scientific Title	risk-reducing surgery for pathogenic variant carriers of gynecologic hereditary tumors
Scientific Title:Acronym	risk-reducing surgery for pathogenic variant carriers of gynecologic hereditary tumors
Region	Japan

Condition
Condition	Unaffected pathogenic variant carriers of hereditary gynecologic tumors
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	in preparation
Basic objectives2	Others
Basic objectives -Others	in preparation
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	in preparation
Key secondary outcomes	in preparation

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	Gene 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	Not applicable
Gender	Female
Key inclusion criteria	in preparation
Key exclusion criteria	No
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yusuke Middle name Last name Kobayashi
Organization	Keio University School of Medicine
Division name	Department of Obstetrics & Gynecology
Zip code	1608582
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
TEL	03-3353-1211
Email	kobax@a2.keio.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Kobayashi
Organization	Keio University School of Medicine
Division name	Department of Obstetrics & Gynecology
Zip code	1608582
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
TEL	03-3353-1211
Homepage URL
Email	kobax@a2.keio.jp

Sponsor
Institute	Department of Obstetrics & Gynecology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	NA
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	Keio University School of Medicine
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.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	2017 Year 10 Month 11 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	2017 Year 08 Month 22 Day
Date of IRB	2017 Year 10 Month 18 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2037 Year 03 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	2017 Year 10 Month 11 Day
Last modified on	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033726