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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002324
Receipt No. 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

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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
Email

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
Email NCC_IRBoffice@ml.res.ncc.go.jp

Sponsor
Institute national cancer center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002840

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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