UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cohort study of immune-checkpoint-inhibitor antibody treatment in non-small-cell lung cancer
Title of the study (Brief title)	Immune-Checkpoint-Inhibitor Cohort Study
Region	Japan

Condition
Condition	non-small-cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Search for biomarkers to reveal the enabled subgroup immune-checkpoint- inhibitor
Basic objectives2	Others
Basic objectives -Others	Search of biomarkers to predict the immune related adverse effect (irAE) by the immune-checkpoint-inhibitor
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	analysis of peripheral blood mononuclear cell(PBMC)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who are scheduled for administration of nivolumab 2) With written informed consent
Key exclusion criteria	1) Having psychological disorder 2) In addition, the primary doctor judging inappropriate for entry
Target sample size	100

Research contact person
Name of lead principal investigator	Ou Yamaguchi
Organization	Saitama Medical University International Medical Center
Division name	respiratory medicine
Address	Hidaka city, Saitama
TEL	042-984-4111
Email	ouyamagu@saitama-med.ac.jp

Public contact
Name of contact person	Ou Yamaguchi
Organization	Saitama Medical University International Medical Center
Division name	respiratory medicine
Address	Hidaka city, Saitama
TEL	042-984-4111
Homepage URL
Email	ouyamagu@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization	Saitama medical university international medical center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 24 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 01 Month 24 Day
Anticipated trial start date	2016 Year 02 Month 15 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	prpspective cohort study of immune-checkpoint-inhibitor treatment in non-small-cell lung cancer

Management information
Registered date	2016 Year 01 Month 24 Day
Last modified on	2017 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023906