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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040660
Receipt No. 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 2021/01/26

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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
Email 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
Email akshimomura@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

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
Email 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
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 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
2021 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046405

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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