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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Male Breast Cancer | ||
Classification by specialty |
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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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |