UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042523 |
|---|---|
| Receipt number | R000048543 |
| Scientific Title | Efficacy of multiple gene panel testing for hereditary breast cancer and relevance to environmental factors |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2020/11/24 00:30:42 |
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Basic information
Public title
Efficacy of multiple gene panel testing for hereditary breast cancer and relevance to environmental factors
Acronym
Efficacy of multiple gene panel testing for hereditary breast cancer
Scientific Title
Efficacy of multiple gene panel testing for hereditary breast cancer and relevance to environmental factors
Scientific Title:Acronym
Efficacy of multiple gene panel testing for hereditary breast cancer
Region
| Japan |
Condition
Condition
Hereditary breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Improvement of detection rate of pathogenic variant
Improvement of 5 years overall survival rate
Relationship between mutation of moderate risk gene and environmental factors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of pathogenic variant
5 years overall survival rate
Key secondary outcomes
Relationship between mutation of moderate risk gene and environmental factors
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
mammography MRI annual
chemotherapy for six months
DNA damaging agents
Radiotherapy omission
Prophylactic Surgery mastectomy oophorectomy
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
Male and Female
Key inclusion criteria
Breast cancer meeting the criteria of genetic testing for BRCA1/2, TP53, PTEN, CDH1, or STK11
Key exclusion criteria
The patient judged as inappropriate by responsible doctor
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Maeda |
Organization
Faculty of medicine, University of Fukui
Division name
First Department of Surgery
Zip code
910-1193
Address
23-3, Matsuoka, Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776613111
maedah@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Maeda |
Organization
Faculty of medicine, University of Fukui
Division name
First Department of Surgery
Zip code
910-1193
Address
23-3, Matsuoka, Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776613111
Homepage URL
maedah@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
University of Fukui
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
Medical Research Support Center, Fukui University Hospital
Address
23-3, Matsuoka, Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
Tel
0776618529
chiken@ml.u-fukui.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2020 | Year | 11 | Month | 24 | Day |
Last modified on
| 2020 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048543
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
