UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040660 |
|---|---|
| Receipt number | R000046405 |
| Scientific Title | Exploratory analysis of gene profiling and immunohistochemical marker in male breast cancer. |
| Date of disclosure of the study information | 2020/06/08 |
| Last modified on | 2022/12/25 17:35:10 |
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Basic information
Public title
Exploratory analysis of gene profiling and immunohistochemical marker in male breast cancer.
Acronym
Exploratory analysis of gene profiling and immunohistochemical marker in male breast cancer.
Scientific Title
Exploratory analysis of gene profiling and immunohistochemical marker in male breast cancer.
Scientific Title:Acronym
Exploratory analysis of gene profiling and immunohistochemical marker in male breast cancer.
Region
| Japan |
Condition
Condition
Male Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Identifying genetic profiling and immunohistochemical markers specific to male breast cancer
Basic objectives2
Others
Basic objectives -Others
Translational research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Descriptive statistics of comprehensive gene panel analysis, BRCA1 gene methylation analysis, and immunohistochemical marker analysis of male breast cancer specimens
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
Male
Key inclusion criteria
1) Patients who have been diagnosed with male breast cancer
2) Patients who are 20 years of age or older at the time of diagnosis
3) Patients who have a sufficient quantity of specimens (approximately 30 4u thick unstained specimens) collected during the study period in question for measurement.
Key exclusion criteria
Patients who have decided inappropriate to include in this study by the investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Shimomura |
Organization
National Center for Global Health and Medicine
Division name
Breast and Medical Oncology
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku Tokyo
TEL
03-3202-7181
akshimomura@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Shimomura |
Organization
National Center for Global Health and Medicine
Division name
Breast and Medical Oncology
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku Tokyo
TEL
03-3202-7181
Homepage URL
akshimomura@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of the National Center for Global Health and Medicine
Address
1-21-1 Toyama, Shinjuku-ku Tokyo
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.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 | 06 | Month | 08 | 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
103
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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study in which specimens and clinicopathological information from the principal investigator and subordinate institutions are collected and measured
Management information
Registered date
| 2020 | Year | 06 | Month | 05 | Day |
Last modified on
| 2022 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046405
