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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001304
Receipt No. R000001581
Scientific Title Study on quality of circulating tumor cell counting and circulating endothelial cell counting in breast cancer patients
Date of disclosure of the study information 2008/08/08
Last modified on 2015/02/07

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Basic information
Public title Study on quality of circulating tumor cell counting and circulating endothelial cell counting in breast cancer patients
Acronym Study on quality of circulating tumor cell counting
Scientific Title Study on quality of circulating tumor cell counting and circulating endothelial cell counting in breast cancer patients
Scientific Title:Acronym Study on quality of circulating tumor cell counting
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Estimation of the quality of circulating tumor cell counting in individual patients with breast cancer
Basic objectives2 Others
Basic objectives -Others Estimation of the quality of circulating endothelial cell counting in individual patients with breast cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Average and standard deviation of CTC counting in individuals
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1) Females with histologically confirmed breast cancer
2) Twenty years old or older
3) Plan to initiate chemotherapy, molecular targetting therapy, hormonal therapy or surgery
4) Written informed consent
Key exclusion criteria 1) Apparent risk for bleeding
2) Inappropriate cases judged by doctors in charge
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Toi
Organization Kyoto University Hospital
Division name Breast Surgery
Zip code
Address 54 Kawaracho Shogoin Sakyo-ku Kyoto
TEL 0757513660
Email toi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Ueno
Organization Kyoto Univiersity
Division name Department of Surgery
Zip code
Address 54 Kawaracho Shogoin Sakyo-ku Kyoto
TEL 0757513660
Homepage URL
Email takayuki@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Surgery Kyoto University Hospital
Institute
Department

Funding Source
Organization Fund obtained by Department of Surgery Kyoto University
Organization
Division
Category of Funding Organization Self funding
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
2008 Year 08 Month 08 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
2008 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Registration Open

Management information
Registered date
2008 Year 08 Month 07 Day
Last modified on
2015 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001581

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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