UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014245 |
|---|---|
| Receipt number | R000016594 |
| Scientific Title | The exploratory study for the drug-predictive markers of TS-1 in metastatic or recurrent breast cancer; Translational biomarker study of SELECT BC trial |
| Date of disclosure of the study information | 2014/06/12 |
| Last modified on | 2018/10/12 13:39:20 |
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Basic information
Public title
The exploratory study for the drug-predictive markers of TS-1 in metastatic or recurrent breast cancer; Translational biomarker study of SELECT BC trial
Acronym
SELECT BC - the better drug predictive
marker analysis (SELECT BC-EURECA)
Scientific Title
The exploratory study for the drug-predictive markers of TS-1 in metastatic or recurrent breast cancer; Translational biomarker study of SELECT BC trial
Scientific Title:Acronym
SELECT BC - the better drug predictive
marker analysis (SELECT BC-EURECA)
Region
| Japan |
Condition
Condition
Metastatic or recurrent breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To find the predictive biomarkers of TS-1 for the breast cancer based on expression of mRNA related with 5-FU metabolism using samples from patients who participated in SELECT BC trial
Basic objectives2
Others
Basic objectives -Others
Transralational research for predictive biomarker of TS-1
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between the bio-marker and clinical efficacy, i.e. PFS: progression free survival, of each patient who has participated in SELECT BC trial
Key secondary outcomes
Correlation between the bio-marker and clinical efficacy, i.e. TTF:Time to Treatment Failure, OS:Overall survival, and DCR:Disease control rate, of each patient who has participated in SELECT BC trial
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Institutional review board (IRB) approval for research and transportation of breast cancer samples
2) Availability to obtain surgical specimen or core needle biopsy sample of breast cancer
Key exclusion criteria
1) Patients not adequate for participation in this study at doctors' discretion.
2) Patients not obtained informed consentnot obtained informed consent
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumikata Hara |
Organization
National Hospital Organization Shikoku Cancer Center
Division name
Department of breast oncology
Zip code
Address
160 Kou, Minamiumemoto-chou, Matsuyama
TEL
089-999-1111
hfumikat@shikoku-cc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamao |
Organization
Public Health Research Foundation
Division name
Comprehensive Support Project for Oncology Research
Zip code
Address
1-1-7, Nishiwaseda, Shinjyuku-ku Tokyo,
TEL
03-5287-2636
Homepage URL
http://www.csp.or.jp/
support@csp.or.jp
Sponsor or person
Institute
SELECT BC executive committee
Institute
Department
Personal name
Funding Source
Organization
Public Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2014 | Year | 06 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2014 | Year | 06 | Month | 12 | Day |
Last modified on
| 2018 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016594
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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