UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042155 |
|---|---|
| Receipt number | R000048118 |
| Scientific Title | TP53 germline mutation testing in breast cancer |
| Date of disclosure of the study information | 2020/10/30 |
| Last modified on | 2020/10/25 20:34:10 |
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Basic information
Public title
The study of surveillance in breast cancer with germline TP53 mutation
Acronym
TP53 germline mutation testing in breast cancer
Scientific Title
TP53 germline mutation testing in breast cancer
Scientific Title:Acronym
The study of surveillance in breast cancer with germline TP53 mutation
Region
| Japan |
Condition
Condition
Hereditary breast cancer with germline TP53 mutation
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Improvement of 5year overall survival rate in hereditary breast cancer with germline TP53 mutation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The detection of asymptomatic malignant tumours relevant to Li-Fraumeni syndrome after the treatment of breast cancer for 10 years
Key secondary outcomes
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
Prevention
Type of intervention
| Gene | Device,equipment |
Interventions/Control_1
Biochemical and imaging surveillance in breast cancer with TP53 germline mutation after treatment of breast cancer for 10 years
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
Female
Key inclusion criteria
Breast cancer patients examined for TP53 germline testing
Key exclusion criteria
Breast cancer patients evaluated not to be appropriate for this study by the reseacher in charge
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
Faculty of medicine, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Faculty of medicine, 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
University of Fukui hospital, medical research support center
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
| 2020 | Year | 10 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 01 | 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 | 10 | Month | 18 | Day |
Last modified on
| 2020 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048118
