UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003478 |
|---|---|
| Receipt number | R000004209 |
| Scientific Title | Ultrasound criteria to evaluate for early response to neoadjuvant chemotherapy in breast cancer |
| Date of disclosure of the study information | 2010/05/01 |
| Last modified on | 2010/04/12 16:29:43 |
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Basic information
Public title
Ultrasound criteria to evaluate for early response to neoadjuvant chemotherapy in breast cancer
Acronym
JABTS BC03
Scientific Title
Ultrasound criteria to evaluate for early response to neoadjuvant chemotherapy in breast cancer
Scientific Title:Acronym
JABTS BC03
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Ultrasound criteria to evaluate for early response to neoadjuvant chemotherapy in breast cancer is made.
The relationship of the criteria and pCR rate at surgery is invastigated in a clinical trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ultrasound criteria to evaluate for early response to neoadjuvant chemotherapy in breast cancer was made.
The rate of the responder and the non-responder in this criteria is compare to the rate pCR at surgery.
Key secondary outcomes
Quality control of the ultrasound criteria to evaluate for early response to neoadjuvant chemotherapy in breast cancer.
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
Female
Key inclusion criteria
The breast cancer patients for the neoadjuvant chemotherapy as primary systemic treatment.
Key exclusion criteria
No remarkable criteria
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Nakashima |
Organization
Kawasaki Medical School
Division name
Breast and Thyroid Surgery
Zip code
Address
577 Matsushima Kurashiki Okayama
TEL
086-462-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kawasaki Medical School
Division name
Breast and Thyroid Surgery
Zip code
Address
TEL
Homepage URL
urbandoc@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Japan Association of Breast and Thyroid Sonology
Institute
Department
Personal name
Funding Source
Organization
Japan Association of Breast and Thyroid Sonology
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
| 2010 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | 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
Ultrasound criteria to evaluate for early response to neoadjuvant chemotherapy in breast cancer was made.
The rate of the responder and the non-responder in this criteria is compare to the rate pCR at surgery.
Management information
Registered date
| 2010 | Year | 04 | Month | 12 | Day |
Last modified on
| 2010 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004209
