UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020716
Receipt number R000023902
Scientific Title Studyy for the QOL changes before and after RRSO(Risk Reducing Salpingo-Oophorectomy) in HBOC patients
Date of disclosure of the study information 2016/01/25
Last modified on 2019/04/22 07:41:12

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Basic information

Public title

Studyy for the QOL changes before and after RRSO(Risk Reducing Salpingo-Oophorectomy) in HBOC patients

Acronym

RRSO QOL Study

Scientific Title

Studyy for the QOL changes before and after RRSO(Risk Reducing Salpingo-Oophorectomy) in HBOC patients

Scientific Title:Acronym

RRSO QOL Study

Region

Japan


Condition

Condition

Hereditary breast ovarian cancer syndrome

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Investigating the QOL changes in the HBOC patients before and after RRSO

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes of QOL

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

Other

Interventions/Control_1

Questionnaire

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

Over 20 year old, hope for RRSO, germline BRCA1/2 mutation(+)

Key exclusion criteria

no criteria

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nishikawa Ryutaro

Organization

Nagoya city east medical center

Division name

Gynecology

Zip code


Address

1-2-23 Wakamizu, Chikusa-Ku, Nagoya-City

TEL

052-721-7171

Email

hidymryu@quartz.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nishikawa Ryutaro

Organization

Nagoya city east medical center

Division name

Gynecology

Zip code


Address

1-2-23 Wakamizu, Chikusa-Ku, Nagoya-City

TEL

052-721-7171

Homepage URL


Email

hidymryu@quartz.ocn.ne.jp


Sponsor or person

Institute

Nagoya city east medical center

Institute

Department

Personal name



Funding Source

Organization

Patient

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


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

2016 Year 01 Month 25 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

Main results already published

Date of protocol fixation

2014 Year 06 Month 05 Day

Date of IRB

2014 Year 06 Month 05 Day

Anticipated trial start date

2014 Year 07 Month 01 Day

Last follow-up date

2017 Year 07 Month 28 Day

Date of closure to data entry

2017 Year 07 Month 28 Day

Date trial data considered complete

2017 Year 07 Month 28 Day

Date analysis concluded

2017 Year 08 Month 31 Day


Other

Other related information

QOL


Management information

Registered date

2016 Year 01 Month 24 Day

Last modified on

2019 Year 04 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023902


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name