UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005172 |
|---|---|
| Receipt number | R000005294 |
| Scientific Title | Development of molecular test for breast cancer |
| Date of disclosure of the study information | 2011/03/03 |
| Last modified on | 2017/03/06 15:55:25 |
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Basic information
Public title
Development of molecular test for breast cancer
Acronym
Development of molecular test for breast cancer
Scientific Title
Development of molecular test for breast cancer
Scientific Title:Acronym
Development of molecular test for breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to develop molecular test for prognosis or chemo sensitivity in breast cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
predictability of prognosis.
predictability of chemo sensitivity
Key secondary outcomes
correlation of TP53 mutation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
breast cancer patient
concent to this study
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Takahashi |
Organization
Tohoku univ. hosp.
Division name
Department of Medical Oncology
Zip code
Address
1-1, Seiryo-machi, Aobaku, Miyagi, Japan
TEL
022-717-8547
swt@idac.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin Takahashi |
Organization
Tohoku univ. hosp.
Division name
Department of Medical Oncology
Zip code
Address
1-1, Seiryo-machi, Aobaku, Miyagi, Japan
TEL
022-717-8547
Homepage URL
swt@idac.tohoku.ac.jp
Sponsor or person
Institute
Department of Medical Oncology, Tohoku univ. hosp.
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2011 | Year | 03 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/doi/10.1111/j.1349-7006.2007.00691.x/abstract
Number of participants that the trial has enrolled
Results
Cancer Sci. 2008 Feb;99(2):324-32.
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
| 2003 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 06 | 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
<Object>
The object of this study is to develop diagnostic biomarkers for breast cancer patients.
(1) To identify expression profiles that can predict the prognosis of breast cancer patients, and to develop more convenient methods to analyze these expression profiles.
(2) To develop molecular diagnostic tools to examine the status of known molecular markers (expression of hormone receptor, uPA/PAI-1, HER2/neu and c-myc, TP53 gene mutation) using expression profiles.
(3) To identify difference of molecular mechanisms of invasive micropapillary carcinoma which is one of the most malignant subtype of breast cancer and invasive ductal carcinoma which is the most common subtype of breast cancer by microarray analysis.
<Subject>
Breast cancer patients who undergo surgery or biopsy with informed consent to this study.
<Methods>
This study is approved by ethics committee of Tohoku University.
Recruitment of the patients starts in June, 2003.
Clinicopathological information is obtained from patient records. Surgical or biopsy specimens are frozen and stored in -80 degree celsius. Total RNA and DNA are extracted from the tumor tissues, and stored in -80 degree celsius until the subsequent analysis. Total RNA is used for Microarray analysis and DNA is used for sequence analysis. Gene sets correlate to prognosis or those molecular marker status are identified by statistical analysis.
Management information
Registered date
| 2011 | Year | 03 | Month | 02 | Day |
Last modified on
| 2017 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005294
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
