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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038518
Receipt No. R000043891
Scientific Title Advanced Breast Cancer Database (ABCD) project
Date of disclosure of the study information 2019/11/08
Last modified on 2019/11/08

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Basic information
Public title Advanced Breast Cancer Database (ABCD) project
Acronym JBCRG-ABCD project
Scientific Title Advanced Breast Cancer Database (ABCD) project
Scientific Title:Acronym JBCRG-ABCD project
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 (1) Establish a nationwide advanced breast cancer registry in Japan.
(2) Promote patient enrollment in ongoing trials for ABC by using patient information from the database.
(3) Promote retrospective research for ABC by using the nationwide database.
(4) Visualize a pattern of care and treatment for ABC in Japanese institutions.
(5) Establish a foundation for identifying eligible cases retrospectively and conducting research using residual specimens.
(6) Contribute to promote clinical research by using database information as basic data for future prospective clinical research. Entrust survey requests using this database based on a separate procedure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall Survival
Key secondary outcomes Time to Treatment Failure

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 (1) Age over 20 years old and historically confirmed Breast cancer.
(2) Confirmed metastatic or advance breast cancer after 1st January 2017.
(3) Informed consent is obtainable.
Key exclusion criteria None
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Niikura
Organization Tokai University School of Medicine
Division name Department of Breast and Endocrine Surgery
Zip code 259-1193
Address Shimokasuya 143, Isehara-shi, Kanagawa, JAPAN
TEL 0463-93-1121
Email niikura@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name Katsumasa
Middle name
Last name Kuroi
Organization Japan Breast Cancer Research Group (JBCRG)
Division name Head Office
Zip code 103-0016
Address Nihonbashikoamicho9-4, Chuo-ku, Tokyo, JAPAN
TEL 03-6264-8873
Homepage URL https://www.jbcrg.jp
Email office@jbcrg.jp

Sponsor
Institute Japan Breast Cancer Research Group (JBCRG)
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board for Clinical Research, Tokai University
Address Shimokasuya 143, Isehara-shi, Kanagawa, JAPAN
Tel 0463-93-1121
Email tokai-rinsho@ml.tokai-u.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 東海大学医学部(神奈川県)、相良病院(鹿児島県)、 福島県立医科大学(福島県)

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 08 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
2019 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 01 Day
Last follow-up date
2029 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This project will be implemented as a multi-facility joint project using a central registration system.
Registration is based on prior informed consent of the patient.
To conduct any research using the database of this project, a new research protocol should be submitted to JBCRG.

Management information
Registered date
2019 Year 11 Month 08 Day
Last modified on
2019 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043891

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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