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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026768
Receipt No. R000030722
Scientific Title A randomized controlled trial to evaluate the effectiveness of personalized genetic breast cancer risk feedback for non-breast cancer women
Date of disclosure of the study information 2017/04/17
Last modified on 2018/09/06

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Basic information
Public title A randomized controlled trial to evaluate the effectiveness of personalized genetic breast cancer risk feedback for non-breast cancer women
Acronym Breast cancer risk feedback RCT
Scientific Title A randomized controlled trial to evaluate the effectiveness of personalized genetic breast cancer risk feedback for non-breast cancer women
Scientific Title:Acronym Breast cancer risk feedback RCT
Region
Japan

Condition
Condition Breast cancer prevention behavior
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the effectiveness of personalized genetic breast cancer risk feedback for non-breast cancer women
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Frequency of breast self-examination
Key secondary outcomes Frequency and type of breast cancer screening, Lifestyle changes (BMI, physical activity, alcohol consumption, etc)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Gene Other
Interventions/Control_1 Personalized breast cancer risk feedback based on individuals' genetic polymorohism and their lifestyles
Interventions/Control_2 Personalized breast cancer risk feedback based on individuals' lifestyles
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
30 years-old <=
Age-upper limit
70 years-old >
Gender Female
Key inclusion criteria 1.Individuals who had a diagnostic test at Aichi Cancer Center
2.Individuals who are not diagnosed with breast cancer
3.30-69 years old women
4.no past history of cancer
5. Individuals who sign the consent document after explanation of this study
Key exclusion criteria 1.Individuals who need regular follow-up after their initial medical examinations.
2.Individuals who had a commercial genetic testing
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keitaro Matsuo
Organization Aichi Cancer Center Research Institute
Division name Division of Molecular and Clinical Epidemiology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL 052-764-9828
Email molemed3@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keitaro Matsuo
Organization Aichi Cancer Center Research Institute
Division name Division of Molecular and Clinical Epidemiology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL 052-764-9828
Homepage URL http://www.pref.aichi.jp/cancer-center/ri/01bumon/04idenshi_iryo/09c/homepage/index.html
Email molemed3@aichi-cc.jp

Sponsor
Institute Division of Molecular and Clinical Epidemiology, Aichi Cancer Center Research Institute
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 愛知県がんセンター研究所
Aichi Cancer Center Research Institute

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 17 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 No longer recruiting
Date of protocol fixation
2017 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 29 Day
Last modified on
2018 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030722

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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