UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010665 |
|---|---|
| Receipt number | R000012473 |
| Scientific Title | Assessment of IHC-Ki67 after short-term neoadjuvant hormone therapy in hormone receptor positive breast cancer |
| Date of disclosure of the study information | 2013/10/10 |
| Last modified on | 2018/05/13 08:51:17 |
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Basic information
Public title
Assessment of IHC-Ki67 after short-term neoadjuvant hormone therapy in hormone receptor positive breast cancer
Acronym
Assessment of IHC-Ki67 after short-term neoadjuvant hormone therapy
Scientific Title
Assessment of IHC-Ki67 after short-term neoadjuvant hormone therapy in hormone receptor positive breast cancer
Scientific Title:Acronym
Assessment of IHC-Ki67 after short-term neoadjuvant hormone therapy
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objective is to test feasibilities of IHC-Ki67 after short term neoadjuvant hormone therapy by gene expression profiling and establish the novel biomarker for hormone receptor positive breast cancers.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IHC-Ki67 and gene expression before and after short-term neoadjuvant hormone therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
2weeks-Neoadjuvant hormone therapy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non treated primary invasive ductal breast cancers
Estrogen receptor or Progesterone receptor positive ≥ 10% and HER2/FISH test
Tumor size ≥ 10mm
Key exclusion criteria
Neoadjuvant chemotherapy
Inoperable
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyoshi Doihara |
Organization
Okayama University Hospital
Division name
Breast and Endocrine surgery
Zip code
Address
2-5-1 Shikata-cho, Kitaku, Okayama city, Okayama, Japan
TEL
086-235-6502
hdoihara@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Iwamoto |
Organization
Okayama University Hospital
Division name
Breast and Endocrine surgery
Zip code
Address
2-5-1 Shikata-cho, Kitaku, Okayama city, Okayama, Japan
TEL
086-235-6502
Homepage URL
xjrtaka@hotmail.com
Sponsor or person
Institute
Hiroyoshi Doihara
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Preinitiation
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
| 2013 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2013 | Year | 05 | Month | 08 | Day |
Last modified on
| 2018 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012473
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
