UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035334
Receipt No. 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 2018/12/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last name of lead principal investigator
1st name
Middle name
Last name Reo Maruyama
Organization Japanese Foundation for Cancer Research
Division name Project for Cancer Epigenomics, Cancer Institute
Zip code
Address Ariake 3-8-31, Koto-ku, Tokyo
TEL 03-3520-0111
Email reo.maruyama@jfcr.or.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Reo Maruyama
Organization Japanese Foundation for Cancer Research
Division name Project for Cancer Epigenomics, Cancer Institute
Zip code
Address Ariake 3-8-31, Koto-ku, Tokyo
TEL 03-3520-0111
Homepage URL
Email reo.maruyama@jfcr.or.jp

Sponsor
Institute Japanese Foundation for Cancer Research
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2019 Year 01 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 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
2018 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040257

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.