UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of predictive factors of adverse events and therapeutic effects of immune checkpoint inhibitors in patients with solid cancer.
Title of the study (Brief title)	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	Kazuyuki HAMADA
Organization	Showa University School of Medicine
Division name	Department of Internal Medicine,Division of Medical Oncology
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	Kazuyuki HAMADA
Organization	Showa University School of Medicine
Division name	Department of Internal Medicine,Division of Medical Oncology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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