UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002320
Receipt No. 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

* 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 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
Email

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

Sponsor
Institute national cancer center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002838

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.