UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038518 |
|---|---|
| Receipt number | R000043891 |
| Scientific Title | Advanced Breast Cancer Database (ABCD) project |
| Date of disclosure of the study information | 2019/11/08 |
| Last modified on | 2023/05/17 12:14:42 |
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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) 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
Data collection of advanced and recurrent breast cancer cases in Japan
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
(1) Age over 20 years old and historically confirmed Breast cancer.
(2) Confirmed metastatic or advance breast cancer after 1st January 2017.
(3) Patients who have been fully informed of the details of the study and have given their written consent to participate, unless there are reasons for difficulty in obtaining consent, such as death or transfer to a different hospital. Patients with reasons that make it difficult to obtain consent may opt out.
Key exclusion criteria
None
Target sample size
10000
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
niikura@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Fukase |
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
office@jbcrg.jp
Sponsor or person
Institute
Japan Breast Cancer Research Group (JBCRG)
Institute
Department
Personal name
Funding Source
Organization
Japan Breast Cancer Research Group (JBCRG)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Pfizer Japan Inc. (Quality Improvement Grant, 2020.01.01-2022.12.31)
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
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）ほか
https://jbcrg.jp/clinicaltrials/1621/
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 22 | 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
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.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 |
