UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035334 |
|---|---|
| Receipt number | R000040257 |
| Scientific Title | Identification of novel stratification markers and therapeutic targets of breast cancer based on epigenomic information |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2021/06/23 12:32:13 |
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Basic information
Public title
Identification of novel stratification markers and therapeutic targets of breast cancer based on epigenomic information
Acronym
epigenomic analysis of breast cancer
Scientific Title
Identification of novel stratification markers and therapeutic targets of breast cancer based on epigenomic information
Scientific Title:Acronym
epigenomic analysis of breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
we aim to establish a new stratification method for breast cancer based on epigenome information and to identify molecular abnormalities specific to each subclass that can be candidates for new therapeutic targets.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
therapeutic response, prognosis
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
It is judged clinically that a mammary gland histologic examination (needle biopsy, mammotome biopsy, excisional biopsy) is necessary, or resection of the mammary gland (tumor resection, partial breast excision, mastectomy) is necessary as a treatment Case
Age at registration is over 20 years old
Regarding participation in this study, written informed consent has been obtained from the patient himself / herself
Key exclusion criteria
Case doctors judge that participation in this study is inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Reo |
| Middle name | |
| Last name | Maruyama |
Organization
Japanese Foundation for Cancer Research
Division name
Project for Cancer Epigenomics, Cancer Institute
Zip code
135-8550
Address
Ariake 3-8-31, Koto-ku, Tokyo
TEL
03-3520-0111
reo.maruyama@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Reo |
| Middle name | |
| Last name | Maruyama |
Organization
Japanese Foundation for Cancer Research
Division name
Project for Cancer Epigenomics, Cancer Institute
Zip code
135-8550
Address
Ariake 3-8-31, Koto-ku, Tokyo
TEL
03-3520-0111
Homepage URL
reo.maruyama@jfcr.or.jp
Sponsor or person
Institute
Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Foundation for Cancer Research
Address
Ariake 3-8-31, Koto-ku, Tokyo
Tel
03-3520-0111
reo.maruyama@jfcr.or.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
| 2019 | Year | 01 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will use part of biopsied or excised tissue for diagnosis or treatment during examination or surgical operation at the Cancer Institute Hospital.
Management information
Registered date
| 2018 | Year | 12 | Month | 21 | Day |
Last modified on
| 2021 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040257
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
