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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031709
Receipt No. R000036090
Scientific Title A randomized controlled trial to evaluate the effectiveness of genetic cancer risk prediction for female screening non-responders
Date of disclosure of the study information 2018/03/13
Last modified on 2018/09/12

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Basic information
Public title A randomized controlled trial to evaluate the effectiveness of genetic cancer risk prediction for female screening non-responders
Acronym Commercial genetic cancer risk feedback RCT
Scientific Title A randomized controlled trial to evaluate the effectiveness of genetic cancer risk prediction for female screening non-responders
Scientific Title:Acronym Commercial genetic cancer risk feedback RCT
Region
Japan

Condition
Condition Cancer prevention behavior
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the behavior modification for cancer prevention among female screening non-responders by commercial genetic cancer risk prediction
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Breast and cervical cancer screening rate
Key secondary outcomes Lifestyle change (BMI, physical activity, dietary pattern), psychological effect

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
Interventions/Control_1 Commercial genetic cancer risk prediction and health education for cancer prevention
Interventions/Control_2 Health education for cancer prevention
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
45 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria 1. 45-49 years old women
2. No past history of cancer
3. Breast and cervical cancer screening non-responders
4. Individuals who can attend the study explanation meeting
5. Individuals who sign the consent document for explanation of this study
6. Individuals who consent to share the genetic information with researchers
7. Individuals who consent to the follow-up survey regarding the cancer screenings and lifestyle
Key exclusion criteria 1. Past history of cancer
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sadao Suzuki
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Public Health
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
TEL 052-853-8177
Email taisitu@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sadao Suzuki
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Public Health
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
TEL 052-853-8177
Homepage URL
Email taisitu@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Public Health, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science(JSPS)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 名古屋市立大学大学院医学研究科 (Nagoya City University Graduate School of Medical Sciences)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 13 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
2018 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 13 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
2018 Year 03 Month 13 Day
Last modified on
2018 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036090

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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