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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018621
Receipt No. R000021534
Scientific Title The analysis of immune response on the effect of endocrine therapy in breast cancer patients
Date of disclosure of the study information 2015/08/12
Last modified on 2015/08/10

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Basic information
Public title The analysis of immune response on the effect of endocrine therapy in breast cancer patients
Acronym Immune response on the effect of endocrine therapy in breast cancer patients
Scientific Title The analysis of immune response on the effect of endocrine therapy in breast cancer patients
Scientific Title:Acronym Immune response on the effect of endocrine therapy in breast cancer patients
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Analyse the immune response during endocrine therapy in breast cancer patients
Basic objectives2 Others
Basic objectives -Others Exploratory research
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Immune response on the effect of endocrine therapy
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
21 years-old <=
Age-upper limit
85 years-old >=
Gender Female
Key inclusion criteria Breast cancer patients undergoing sugery folloed by endcrine therapy
Key exclusion criteria Patinets who received systemic therapy before surgery
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiya Horimoto
Organization Juntendo University School of Medicine
Division name Breast Oncology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email yoshiyahorimoto@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiya Horimoto
Organization Juntendo University School of Medicine
Division name Breast Oncology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email yoshiyahorimoto@hotmail.com

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific 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
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
2015 Year 08 Month 12 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 07 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Investigate patient outcomes

Management information
Registered date
2015 Year 08 Month 10 Day
Last modified on
2015 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021534

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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