UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033751
Receipt number R000038496
Scientific Title Procedure of risk rducing surgery for hereditary gynecologic tumor
Date of disclosure of the study information 2018/10/01
Last modified on 2020/03/20 21:00:43

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Basic information

Public title

Procedure of risk rducing surgery for hereditary gynecologic tumor

Acronym

RRSO

Scientific Title

Procedure of risk rducing surgery for hereditary gynecologic tumor

Scientific Title:Acronym

RRSO

Region

Japan


Condition

Condition

BRCA1, BRCA2,MLH1,MSH2,MSH6,PMS2,BRIP1,RAD51C or RAD51D mutation carriers

Classification by specialty

Hematology and clinical oncology Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Critical prevention of ovarian, fallopian tubal and peritoneal cancer in hereditary tumor-related gene carrires by RRSO

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence rate of ovarian, fallopian tubal and peritoneal cancer

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

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Risk reducing salpingo-oophorectomy

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

45 years-old >

Gender

Female

Key inclusion criteria

BRCA1, BRCA2,MLH1,MSH2,MSH6,PMS2,BRIP1,RAD51C or RAD51D mutation carrier

Key exclusion criteria

Woman affected a gynecology cancer

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Watanabe Takafumi

Organization

Fukushima Medical University

Division name

Obstetrics and Gynecology

Zip code


Address

1 Hikariga-oka, Fukushima City 960-1295, JAPAN

TEL

024-547-1290

Email

t-wata@fmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Watanabe Takafumi

Organization

Fukushima Medical University

Division name

Obstetrics and Gynecology

Zip code


Address

1 Hikariga-oka, Fukushima City 960-1295, JAPAN

TEL

024-547-1290

Homepage URL


Email

t-wata@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name



Funding Source

Organization

No

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


Address


Tel


Email



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

2018 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

Terminated

Date of protocol fixation

2018 Year 10 Month 01 Day

Date of IRB

2020 Year 06 Month 14 Day

Anticipated trial start date

2018 Year 11 Month 01 Day

Last follow-up date

2022 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

2018 Year 08 Month 14 Day

Last modified on

2020 Year 03 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038496


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name