UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020750
Receipt number R000023947
Scientific Title Evaluation of awareness questionnaire survey for breast cancer screening examinees
Date of disclosure of the study information 2016/02/01
Last modified on 2019/01/28 10:28:48

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Basic information

Public title

Evaluation of awareness questionnaire survey for breast cancer screening examinees

Acronym

Evaluation of awareness questionnaire survey for breast cancer screening examinees

Scientific Title

Evaluation of awareness questionnaire survey for breast cancer screening examinees

Scientific Title:Acronym

Evaluation of awareness questionnaire survey for breast cancer screening examinees

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery Laboratory medicine Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Awareness survey of breast cancer examinees

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Awareness survey of benefit & harm of breast cancer screening.

Key secondary outcomes

Awareness survey of dense breast screening mammography.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

70 years-old >

Gender

Female

Key inclusion criteria

breast cancer screening examines.

Key exclusion criteria

not consent

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kouichirou Tsugawa

Organization

St.mariannna university school of medicine

Division name

Mammary gland and Endocrine Surgery

Zip code


Address

2-16-1 Sugao Miyamae Kawasaki-city

TEL

044-977-8111

Email

Koitsuga@marianna-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuka Goto

Organization

University of St.mariannna

Division name

breast & imaging center

Zip code


Address

6-7-2 Manpukuji Asao Kawasaki-city

TEL

044-969-7720

Homepage URL


Email

xkitagawa@marianna-u.ac.jp


Sponsor or person

Institute

University of St.marianna

Institute

Department

Personal name



Funding Source

Organization

University of St.marianna

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

聖マリアンナ医科大学・大学病院(神奈川県)、聖マリアンナ医科大学東横病院(神奈川県)、聖マリアンナ医科大学西部病院(神奈川県)、川崎市立多摩病院(神奈川県)、聖マリアンナ医科大学附属ブレスト&イメージング先端医療センター(神奈川県)


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2016 Year 01 Month 20 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete

2017 Year 03 Month 31 Day

Date analysis concluded

2018 Year 10 Month 31 Day


Other

Other related information

From February 1, 2016 to March 31, 2017 all that meet the selection criteria in patients who were admitted to our facility.


Management information

Registered date

2016 Year 01 Month 26 Day

Last modified on

2019 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023947


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/02/14 UMINU_アンケート.pptx