UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031709 |
|---|---|
| Receipt number | 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 | 2022/09/15 10:30:47 |
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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 | Sadao |
| Middle name | |
| Last name | Suzuki |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Public Health
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
TEL
052-853-8177
taisitu@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Sadao |
| Middle name | |
| Last name | Suzuki |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Public Health
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
TEL
052-853-8177
Homepage URL
taisitu@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Public Health, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
Nagoya City University Graduate School of Medical Sciences
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
Tel
052-858-7215
clinical_research@med.nagoya-cu.ac.jp
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
144
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
| 2018 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 13 | 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 | 03 | Month | 13 | Day |
Last modified on
| 2022 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036090
