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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025796
Receipt No. R000029667
Scientific Title Prospective study on Pharmacodynamics, the biomarkers of the immune-related adverse events (irAE) and the mechanisms of irAE in solid cancer patients treated with immune-checkpoint inhibitor.
Date of disclosure of the study information 2017/01/22
Last modified on 2018/01/31

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Basic information
Public title Prospective study on Pharmacodynamics, the biomarkers of the immune-related adverse events (irAE) and the mechanisms of irAE in solid cancer patients treated with immune-checkpoint inhibitor.
Acronym Pharmacodynamic analysis and the mechanism of immune-related adverse events in immune-checkpoint inhibitor.
Scientific Title Prospective study on Pharmacodynamics, the biomarkers of the immune-related adverse events (irAE) and the mechanisms of irAE in solid cancer patients treated with immune-checkpoint inhibitor.
Scientific Title:Acronym Pharmacodynamic analysis and the mechanism of immune-related adverse events in immune-checkpoint inhibitor.
Region
Japan

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

Objectives
Narrative objectives1 To Investigate Relation between occupation rate of PD-1 receptor on Tcells and clinical effect and occurrence of immune-related adverse events.
Basic objectives2 Others
Basic objectives -Others Search for biomarkers on immune-related adverse events and therapeutic effects.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relation between occupation rate of PD-1 receptor on Tcells and clinical effect and occurrence of immune-related adverse events.
Key secondary outcomes Identify autoantigens that cause immunological adverse events.To confirm whether thyroid autoantibodies are predictors of thyroid dysfunction. Relationship between immunological adverse event and response rate, duration of response, progression-free survival time, overall survival time, PD-L1, HLA class I, II .
The relationship between immune-related proteins (PD-L1) expression of tumor tissue and predictions of therapeutic effect and irAE.

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 (1) ECOG performance status (PS) of 0 to 2.
(2) Age of more than 20 years old.
(3) Written informed consent.
Key exclusion criteria 1) History of severe hypersensitivity to drugs used in this study.
(2) Within 14 days administer other antineoplastic agent before treatment of immune checkpoint inhibitors.
(3) Active infection.
(4) HBs antigen, HCV antibody and HIV antibody is positive.
(5) Pregnacy or patient's hope to be pregnant.
(6) An inappropriate case judged by doctor in charge.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyuki Hamada
Organization Showa University
Division name Department of Internal Medicine,Division of Medical Oncology
Zip code
Address 1-5-8,hatanodai,shinagawa-ku,Tokyo 142-8666,JAPAN
TEL 03-3784-8000
Email hamadakaz@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyuki Hamada
Organization Showa University
Division name Department of Internal Medicine,Division of Medical Oncology
Zip code
Address 1-5-8,hatanodai,shinagawa-ku,Tokyo 142-8666,JAPAN
TEL 03-3784-8000
Homepage URL
Email hamadakaz@med.showa-u.ac.jp

Sponsor
Institute Department of Internal Medicine,Division of Medical Oncology, Showa University School of Medicine.
Institute
Department

Funding Source
Organization Department of Internal Medicine,Division of Medical Oncology, Showa University School of Medicine.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Clinial Research Institute of Clinical Pharmacology and Therapeutics, Showa University.
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 昭和大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 22 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 Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information An observational study of solid cancer Patients who are being treated with Anticancer drug at Showa University Hospital and meet to our inclusion criteria.
We will obtain peripheral blood mononucear cells and plasma sample from the patients.
We are going to measure plasma levels of cytokines (e.g. IFN-g , TNF-a , IL-4,5,6), PD-L1, PD-L2 and VEGF.
We are going to measure lymphocyte subset activation and PD - 1 receptor occupation rate of immune-checkpoint inhibitor on peripheral blood T lymphocyte.

Management information
Registered date
2017 Year 01 Month 22 Day
Last modified on
2018 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029667

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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