UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035772 |
|---|---|
| Receipt number | R000040558 |
| Scientific Title | Identification of prognostic factors in locally advanced and recurrent patients (multicenter collaborative research) |
| Date of disclosure of the study information | 2019/02/08 |
| Last modified on | 2020/01/20 10:40:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Identification of prognostic factors in locally advanced and recurrent patients (multicenter collaborative research)
Acronym
Identification of prognostic factors in locally advanced and recurrent breast cancer patients
Scientific Title
Identification of prognostic factors in locally advanced and recurrent patients (multicenter collaborative research)
Scientific Title:Acronym
Identification of prognostic factors in locally advanced and recurrent breast cancer patients
Region
| Japan |
Condition
Condition
Local advanced and recurrent metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prognosis of recurrent breast cancer has improved with progress of therapeutic drugs. However, in what order is it most effective to use many drugs, this point is not clear. In estrogen receptor positive breast cancer, generally, starting with endocrine therapy, it shifts to chemotherapy when treatment effect is no longer available. However, some cases progress rapidly and there are cases where timing to perform chemotherapy is lost, so detecting the prognosis in recurrent patients is useful for treatment selection. Therefore, the purpose of this study is to identify prognostic factors and therapeutic effect predictive factors for locally advanced and recurrent breast cancer patients.
Basic objectives2
Others
Basic objectives -Others
The data to be examined this time are image data, clinical examination data, treatment effect, prognosis etc. to be carried out in routine practice. The above data is extracted from medical record. The period for collecting information is five years of this research period. The subject of this survey is about 200 cases treated by Hyogo College of Medicine for local progression or recurrence. From the collaborative research institute, 100 cases are scheduled.
This study is expected to identify factors that influence the prognosis and therapeutic effect of recurrent patients, and the results provide useful information in selecting treatment methods in routine practice.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
progression free survival
Key secondary outcomes
clinical benefit
overall survival
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing treatment for locally advanced and recurrent breast cancer at Hyogo college of Medicine and collaborative research institutions and patients who will be receiving research in the future
Key exclusion criteria
Data missing cases
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yasuo miyoshi |
Organization
Hyogo college of Medicine
Division name
Breast and endocrine surgery
Zip code
Address
1-1,Mukogawacho, Nishinomiya-city,Hyogo
TEL
0798-45-6374
ymiyoshi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yasuo miyoshi |
Organization
Hyogo college of Medicine
Division name
Breast and endocrine surgery
Zip code
Address
1-1,Mukogawacho, Nishinomiya-city,Hyogo
TEL
0798-45-6374
Homepage URL
ymiyoshi@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kansai Rosai Hospital
Yao Municipal Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Anticancer Res. 2019 Oct;39(10):5653-5662
Number of participants that the trial has enrolled
100
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The data to be used is data such as image, clinical examination, treatment effect, prognosis etc. to be carried out in routine practice. They are extracted from medical record. This study is expected to be able to identify factors affecting the prognosis and therapeutic effect of recurrent patients, and the results provide useful information for selecting treatment methods in routine practice.
Management information
Registered date
| 2019 | Year | 02 | Month | 04 | Day |
Last modified on
| 2020 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040558
