UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021269 |
|---|---|
| Receipt number | R000024536 |
| Scientific Title | Gene profiling study for the patients with breast cancer |
| Date of disclosure of the study information | 2016/03/07 |
| Last modified on | 2016/03/18 19:08:22 |
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Basic information
Public title
Gene profiling study for the patients with breast cancer
Acronym
Gene profiling study for the patients with breast cancer
Scientific Title
Gene profiling study for the patients with breast cancer
Scientific Title:Acronym
Gene profiling study for the patients with breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify the gene profiling in the patients with breast cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify the gene profiling in the patients with breast cancer
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 and Female
Key inclusion criteria
Breast cancer patient
Key exclusion criteria
None
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetaka Kawabata |
Organization
Toranomon Hospital
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
2-2-2, Toranomon, Minato-ku, Tokyo
TEL
+81-3-3588-1111
h-kawabata@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Tanabe |
Organization
Toranomon Hospital
Division name
Department of Medical Oncology
Zip code
Address
2-2-2, Toranomon, Minato-ku, Tokyo
TEL
+81-3-3588-1111
Homepage URL
ytanabe@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Okinaka memorial Institute for Medical Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-cross sectional study
-Patients are diagnosed with breast cancer
-age: 20 years and older
-Patients may enter this study at any line of therapy
-Patients must have a tumor sample available for genetic examinations
Management information
Registered date
| 2016 | Year | 03 | Month | 01 | Day |
Last modified on
| 2016 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024536
