UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002107 |
|---|---|
| Receipt number | R000002570 |
| Scientific Title | Validation study of algorithms predicting axillary lymph node metastasis from primary breast cancer and predicting the treatment response to neoadjuvant chemotherapy. |
| Date of disclosure of the study information | 2009/06/24 |
| Last modified on | 2009/12/26 13:05:13 |
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Basic information
Public title
Validation study of algorithms predicting axillary lymph node metastasis from primary breast cancer and predicting the treatment response to neoadjuvant chemotherapy.
Acronym
Validation study of algorithms predicting axillary lymph node metastasis from primary breast cancer and predicting the treatment response to neoadjuvant chemotherapy.
Scientific Title
Validation study of algorithms predicting axillary lymph node metastasis from primary breast cancer and predicting the treatment response to neoadjuvant chemotherapy.
Scientific Title:Acronym
Validation study of algorithms predicting axillary lymph node metastasis from primary breast cancer and predicting the treatment response to neoadjuvant chemotherapy.
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to validate the prediction model for axillary lymph node metastasis and that for treatment response to neoadjuvant chemotherapy in an independent data-set from a training data-set.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Area under the ROC curve
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.Histologically confirmed breast cancer patient.
2.Primary breast cancer patient
3.Patient performed sentinel lymph node biopsy or axillary lymph node dissection, or patient performed neoadjuvant chemotherapy
Key exclusion criteria
Not applicable
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Toi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Breast Surgery
Zip code
Address
54 Kawaracho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Takada |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Breast Surgery
Zip code
Address
54 Kawaracho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
Homepage URL
http://www.brca.jp/
masahiro@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Breast Surgery, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institute for Advanced Biosciences, Keio University
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 | 06 | Month | 24 | 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
Date of protocol fixation
| 2009 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study, dealing with retrospective clinical data.
Management information
Registered date
| 2009 | Year | 06 | Month | 23 | Day |
Last modified on
| 2009 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002570
