UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012881 |
|---|---|
| Receipt number | R000015049 |
| Scientific Title | Biomarker study using cell-free DNA from patients with advanced breast cancer |
| Date of disclosure of the study information | 2014/01/17 |
| Last modified on | 2014/01/17 00:51:42 |
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Basic information
Public title
Biomarker study using cell-free DNA from patients with advanced breast cancer
Acronym
cell-free DNA study of breast cancer
Scientific Title
Biomarker study using cell-free DNA from patients with advanced breast cancer
Scientific Title:Acronym
cell-free DNA study of breast cancer
Region
| Japan |
Condition
Condition
advanced breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
detection of PIK3CA and HER2 gene mutation in plasma
Basic objectives2
Others
Basic objectives -Others
detection of gene mutations from cancer cells in plasma
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
frequency of mutation
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
| Not applicable |
Gender
Female
Key inclusion criteria
advanced breast cancer
Key exclusion criteria
HBS antigen positive
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Tsurutani |
Organization
Kinki University Faculty of Medicine
Division name
Medical Oncology department
Zip code
Address
377-2 Ohnohigashi, Osakasayama, Osaka
TEL
072-366-0221
tsurutani_j@dotd.med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junji Tsurutani |
Organization
Kinki University Faculty of Medicine
Division name
Medical Oncology department
Zip code
Address
377-2 Ohnohigashi, Osakasayama, Osaka
TEL
072-366-0221
Homepage URL
tsurutani_j@dotd.med.kindai.ac.jp
Sponsor or person
Institute
Kinki University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kinki University Faculty of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2014 | Year | 01 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
detection of gene mutation in plasma before an anticancer drug, and after failure to the drug
Management information
Registered date
| 2014 | Year | 01 | Month | 17 | Day |
Last modified on
| 2014 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015049
