UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026768 |
|---|---|
| Receipt number | 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 | 2024/10/03 09:55:17 |
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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 | Keitaro |
| Middle name | |
| Last name | Matsuo |
Organization
Aichi Cancer Center Research Institute
Division name
Division of Molecular and Clinical Epidemiology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL
052-764-9828
molemed3@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | Matsuo |
Organization
Aichi Cancer Center
Division name
Division of Molecular and Clinical Epidemiology
Zip code
464-8681
Address
Nagoya
TEL
0528517750
Homepage URL
http://www.pref.aichi.jp/cancer-center/ri/01bumon/04idenshi_iryo/09c/homepage/index.html
molemed3@aichi-cc.jp
Sponsor or person
Institute
Division of Molecular and Clinical Epidemiology, Aichi Cancer Center Research Institute
Institute
Department
Personal name
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
Aichi Cancer Center
Address
Nagoya
Tel
0528517750
irb@aichi-cc.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
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
200
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
| 2016 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The 6-year follow-up survey has been completed. Long-term follow-up is currently underway.
Management information
Registered date
| 2017 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030722
