UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002324 |
|---|---|
| Receipt number | R000002840 |
| Scientific Title | biomarker study of the effect and adverse event for neoadjuvantchemotherapy with breast cancer patinets |
| Date of disclosure of the study information | 2009/08/11 |
| Last modified on | 2011/02/21 16:12:02 |
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Basic information
Public title
biomarker study of the effect and adverse event for neoadjuvantchemotherapy with breast cancer patinets
Acronym
biomarker study for breast cancer neoadjuvant chemotherapy
Scientific Title
biomarker study of the effect and adverse event for neoadjuvantchemotherapy with breast cancer patinets
Scientific Title:Acronym
biomarker study for breast cancer neoadjuvant chemotherapy
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate of predictive biomarker for the pathological complete response with breast cancer neoadjuvant chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
pahological complete response
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients approved informed consent
2) patients who will recieve neoajuvant chemotherapy including Anthracycline and Taxane
3) patinents with measurable lesion with breast ultrasonography
4) patients without concomitant malignancy other than carcinoma in situ
Key exclusion criteria
none
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumiaki Koizumi |
Organization
national cancer center
Division name
Shi-en Shisetu
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumiaki Koizumi |
Organization
national cancer center
Division name
Shi-en Shisetu
Zip code
Address
TEL
Homepage URL
NCC_IRBoffice@ml.res.ncc.go.jp
Sponsor or person
Institute
national cancer center
Institute
Department
Personal name
Funding Source
Organization
To promote basic research by research personnel in private-sector business
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2009 | Year | 08 | Month | 11 | 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
Completed
Date of protocol fixation
| 2007 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2009 | Year | 08 | Month | 11 | Day |
Last modified on
| 2011 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002840
