UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002320 |
|---|---|
| Receipt number | R000002838 |
| Scientific Title | The prediction study of the effect of antibody therapy using antibody dependent cell-mediated cytotoxicity with blood sample |
| Date of disclosure of the study information | 2009/08/11 |
| Last modified on | 2013/02/15 10:15:40 |
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Basic information
Public title
The prediction study of the effect of antibody therapy using antibody dependent cell-mediated cytotoxicity with blood sample
Acronym
ADCC study
Scientific Title
The prediction study of the effect of antibody therapy using antibody dependent cell-mediated cytotoxicity with blood sample
Scientific Title:Acronym
ADCC study
Region
| Japan |
Condition
Condition
malignant solid tumor
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether ADCC analyze with new ADCC assay are associated with clinical outcome and adverse effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the predict of clinical outcome and adverse effect
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
Male and Female
Key inclusion criteria
* healthy volunteer(n=20)
or
* patinets diagnosed as malignant solid tumor with pathology or cytology
and
* patients who will receive or have already received the antibody therapy
Key exclusion criteria
* patients determined ineligible for this study by the researcher
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Fujiwara |
Organization
national cancer center
Division name
breast and medical onoclogy division
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
TEL
03-3541-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Tamura |
Organization
national cancer center
Division name
breast and medical onoclogy division
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
TEL
03-3541-2511
Homepage URL
NCC_IRBoffice@ml.res.ncc.go.jp
Sponsor or person
Institute
national cancer center
Institute
Department
Personal name
Funding Source
Organization
national cancer center
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hitachi Chemical
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 | 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
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 28 | Day |
Other
Other related information
retrospective study
Management information
Registered date
| 2009 | Year | 08 | Month | 11 | Day |
Last modified on
| 2013 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002838
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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