UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042055 |
|---|---|
| Receipt number | R000047996 |
| Scientific Title | Validation study of the prognostic and predictive value of TP53 signature for breast cancer Collateral research |
| Date of disclosure of the study information | 2020/10/09 |
| Last modified on | 2021/10/09 10:11:20 |
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Basic information
Public title
Validation study of the prognostic and predictive value of TP53 signature for breast cancer
Collateral research
Acronym
Collateral research of validation study of TP53 signature
Scientific Title
Validation study of the prognostic and predictive value of TP53 signature for breast cancer
Collateral research
Scientific Title:Acronym
Collateral research of validation study of TP53 signature
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare TP53 signature status of biopsy specimens before preoperative chemotherapy and surgical specimens and to investigate the association between TP53 signature and prognosis.
Basic objectives2
Others
Basic objectives -Others
TP53 signature status after preoperative chemotherapy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TP53 signature status after preoperative chemotherapy
Overall survival
Recurrence free survival
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Female
Key inclusion criteria
Cases enrolled in "Validation study of the prognostic and predictive value of TP53 signature for breast cancer".
Cases in which preoperative chemotherapy was administered.
Key exclusion criteria
Cases considered by the attending physician to be unsuitable for enrollment in this study
Target sample size
107
Research contact person
Name of lead principal investigator
| 1st name | Chikashi |
| Middle name | |
| Last name | Ishioka |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Clinical Oncology
Zip code
981-8575
Address
4-1, Seiryo-machi, Aobaku, Sendai, Miyagi, Japan
TEL
022-717-8543
chikashi@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku University Hospital
Division name
Department of Medical Oncology
Zip code
981-8575
Address
4-1, Seiryo-machi, Aobaku, Sendai, Miyagi, Japan
TEL
022-717-8543
Homepage URL
shin.takahashi.e7@tohoku.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committees of Tohoku University School of Medicine
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan.
Tel
022-717-7000
med-kenkyo@grp.tohoku.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 | 09 | 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
| 2020 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To compare the TP53 signature status of biopsy specimens prior to preoperative chemotherapy and surgical specimens and to determine the association between TP53 signature status and prognosis.
Management information
Registered date
| 2020 | Year | 10 | Month | 08 | Day |
Last modified on
| 2021 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047996
| 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 |
