UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049957 |
|---|---|
| Receipt number | R000056897 |
| Scientific Title | A multicenter cohort study to build better breast cancer care and consensus based on the real world evidence (KBCSG-TR 1316) |
| Date of disclosure of the study information | 2023/01/03 |
| Last modified on | 2023/01/02 23:52:50 |
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Basic information
Public title
A multicenter cohort study to build better breast cancer care and consensus based on the real world evidence (KBCSG-TR 1316)
Acronym
A multicenter cohort study to build better breast cancer care and consensus based on the real world evidence (KBCSG-TR 1316)
Scientific Title
A multicenter cohort study to build better breast cancer care and consensus based on the real world evidence (KBCSG-TR 1316)
Scientific Title:Acronym
Building RWE in Breast Cancer Practice (KBCSG-TR1316)
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To develop a breast cancer practice algorithm that will address various clinical issues in breast cancer care using precisely collected cohort study data analysis to form a consensus and address the increasingly complex individualized treatment of the disease. Through this process, we aim to provide better breast cancer care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Within the scope of clinical, pathological, and imaging data that can be examined based on the clinical data, pathological data, and imaging data that can be collected from medical record information, themes requiring resolution in breast cancer treatment will be established, and primary and secondary endpoints will be established for each theme.
(1) Significance of pCR in preoperative chemotherapy
(2) Axillary lymph node management
(3) Prediction of late recurrence in luminal subtype
(4) Treatment of breast cancer in young patients and significance of LH-RH agonist in premenopausal breast cancer
(5) Treatment algorithm in advanced recurrent breast cancer
(6) Rare disease database construction
(7) Investigation of the optimal timing of PMRT in breast reconstruction
(8) Prediction of appropriate surgical procedures in patients undergoing preoperative chemotherapy
(9) Significance of tumor markers
(10) Exploring the relationship between breast cancer pharmacotherapy and the cancer immune microenvironment
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients must be treated at a facility certified by the Japanese Breast Cancer Society where a Japanese Breast Cancer Society-certified specialist physician works.
(2) Patients whose initial treatment started on or after January 1, 2000
(3) Patients must have a histopathological diagnosis of primary breast cancer.
(4) 20 years of age or older
(5) No disagreement with the use of data in this observational study.
Participating facilities will post a summary of the study on their websites and in outpatient consultation rooms to inform eligible patients (opt-out). All cases from participating facilities that meet the above eligibility criteria will be compiled into a database without arbitrary exclusion (consecutive cases). From the database, more detailed subjects will be selected according to each theme, which will be defined in the analysis plan.
Key exclusion criteria
None stipulated
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Norikazu |
| Middle name | |
| Last name | Masuda |
Organization
Nagoya University Graduate School of Medicine, Department of Breast and Endocrine Surgery
Division name
Department of Breast and Endocrine Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL
0527442251
nmasuda@alpha.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Nakayama |
Organization
KBCSG-TR
Division name
Representative
Zip code
5418567
Address
3-1-69, Otemae, Chuou-ku, Osaka-city, Osaka, Japan
TEL
06-6972-1181
Homepage URL
taqnakayama@hotmail.com
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
self-financing
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
NHO Osaka National Hospital
Address
2-1-14, Hoenzaka, Chuou-ku, Osaka-city, Osaka, Japan
Tel
0669421331
408-chiken@mail.hosp.go.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
| 2023 | Year | 01 | Month | 03 | 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
| 2020 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After IRB approval at each site, breast cancer cases after January 1, 2000 will be reviewed and pooled under opt-out, and then cases appropriate for each research subtheme will be selected. At the same time, prospective cases will be accumulated.
Currently, there are 02 sub-study underway related to Theme 1 and 01, 03 sub-studies related to Theme 5.
1316-01: Multicenter study of HBOC and BRCA1/2 mutation-positive advanced recurrent breast cancer
1316-02: An observational study to determine histologic response to preoperative chemotherapy for operable HER2-positive primary breast cancer
1316-03: A study to predict response to CDK4/6 inhibitor (palbociclib)
Management information
Registered date
| 2023 | Year | 01 | Month | 02 | Day |
Last modified on
| 2023 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056897
| 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 |
