UMIN-CTR Clinical Trial

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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