UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038425 |
|---|---|
| Receipt number | R000043787 |
| Scientific Title | Investigation for prognosis and correlation of therapeutic effect by preoperative chemotherapy and postoperative histopathological diagnosis |
| Date of disclosure of the study information | 2019/10/29 |
| Last modified on | 2025/05/22 13:43:07 |
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Basic information
Public title
Investigation for prognosis and correlation of therapeutic effect by preoperative chemotherapy and postoperative histopathological diagnosis
Acronym
JBCRG-S02
Scientific Title
Investigation for prognosis and correlation of therapeutic effect by preoperative chemotherapy and postoperative histopathological diagnosis
Scientific Title:Acronym
JBCRG-S02
Region
| Japan |
Condition
Condition
Breast cancer which is evaluated pathological and imaging study as clinical CR after PST(Preoperative Systemic Therapy)
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
By to Evaluate the association between cCR and pathological study,
Clearfy the
1. relationship between cCR and pCR
2.relationship between prognosis and cCR
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) accuracy rate of pCR (pCR/cCR)
(2) prognosis (OS,DFS,D-DFS)
(3) each prognosis of pCR, non-pCR
(OS, DFS,D-DFS)
(4) accuracy rate of each intrinsic subtype
(5) prognosis of each intrinsic subtype
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.patients who enrolled JBCRG study
2.image examination was performed after PST
3.diagnosised as clinical CR
4.diagnosised pathological study after operation
5.evaluated prognosis (OS,DFS, D-DFS)
Key exclusion criteria
1.Not recorded pathological study
2.Not performed protocol treatments
3.Not evaluated image examination after PST.
4.Not evaluated pathological study after PST.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Akiyoshi |
Organization
Kyusyu univ. graduate school of medical science
Division name
Department of surgery and science
Zip code
812-8582
Address
3-1-1, maidashi, higashi-ku fukuoka-city
TEL
092-642-5466
sayuakiyoshi@gmail.com
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
9-4-3F,Nihonbashikoamicho,Chuo-ku,Tokyo
TEL
03-6264-8873
Homepage URL
https://jbcrg.jp/
JBCRG-QAG@jbcrg.jp
Sponsor or person
Institute
Japan Breast Cancer Research Group(JBCRG)
Institute
Department
Personal name
Funding Source
Organization
Gunma Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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 | 10 | Month | 29 | 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
400
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 12 | Month | 27 | Day |
Other
Other related information
Study design;meta-analysis of many clinical trials.
Gather the data from database collected by Research group JBCRG, during JUN/2002 to NOV/2016.
As the retrospective observation study, opt-out was done to express the beginning of this research.
Management information
Registered date
| 2019 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043787
