UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001304 |
|---|---|
| Receipt number | 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 11:36:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
takayuki@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Surgery Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001581
