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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025834
Receipt No. R000029708
Scientific Title Study of predictive factors of adverse events and therapeutic effects of immune checkpoint inhibitors in patients with solid cancer.
Date of disclosure of the study information 2017/01/24
Last modified on 2017/01/24

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Basic information
Public title Study of predictive factors of adverse events and therapeutic effects of immune checkpoint inhibitors in patients with solid cancer.
Acronym To Investigate Marker of adverse events and therapeutic effects of immune-checkpoint inhibitors
Scientific Title Study of predictive factors of adverse events and therapeutic effects of immune checkpoint inhibitors in patients with solid cancer.
Scientific Title:Acronym To Investigate Marker of adverse events and therapeutic effects of immune-checkpoint inhibitors
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 the mechanism and predictive markers of immune-related adverse events(irAE) by measuring the PD - 1 receptor occupation rate of immune-checkpoint inhibitor in peripheral blood T lymphocyte.
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 Relationship between the occupancy ratio of immune-checkpoint inhibitors to receptors on peripheral blood CD8 T-lymphocytes and adverse event occurrence in cancer patients with irAE.
Key secondary outcomes 1)Relationship between the occupancy rate of immune-checkpoint inhibitors in peripheral blood mononuclear cell subsets and adverse events, clinical effects (response rate, progression-free survival).
(2)Mononuclear cell fractionation Presence or absence of activation for each cell subtype.
(3)Relationship between occurrence of immunological adverse events and response rate and progression-free survival.
(4)In cancer patients treated with immune checkpoint inhibitors, searching for factors involved in adverse events and therapeutic effects (such as soluble PD-L1, HLA class I and II).

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) Age of more than 20 years old .
(2) Written informed consent.
Key exclusion criteria (1) HBs antigen, HCV antibody, HIV antibody are positive.
(2) An inappropriate case judged by doctor in charge.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyuki HAMADA
Organization Showa University School of Medicine
Division name Department of Internal Medicine,Division of Medical Oncology
Zip code
Address 1-5-8,hatanodai,shinagawa-ku,Tokyo 142-8666,JAPAN
TEL 03-3784-8402
Email hamadakaz@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyuki HAMADA
Organization Showa University School of Medicine
Division name Department of Internal Medicine,Division of Medical Oncology
Zip code
Address 1-5-8,hatanodai,shinagawa-ku,Tokyo 142-8666,JAPAN
TEL 03-3784-8402
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 Department of Immuno Oncology.
Clinical Research Institute of Clinical Pharmacology and
Therapeutics.
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 24 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 11 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 24 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 immune-checkpoint inhibitors at Showa University Hospital and meet to our inclusion criteria.
We obtain peripheral blood mononucear cells and plasma sample from the patients with irAE.
Measurements of plasma levels of cytokines.
To evaluate the lymphocyte activation and PD-1 receptor occupancy in peripheral blood lymphocyte subsets.

Management information
Registered date
2017 Year 01 Month 24 Day
Last modified on
2017 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029708

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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