UMIN-CTR Clinical Trial

Basic information
Public title	A prospective observational study of T cell subsets after administration of immune checkpoint inhibitors in patients with lung cancer
Acronym	pharmacodynamics analysis based on T cell subsets of immune checkpoint inhibitors in patients with lung cancer
Scientific Title	A prospective observational study of T cell subsets after administration of immune checkpoint inhibitors in patients with lung cancer
Scientific Title:Acronym	pharmacodynamics analysis based on T cell subsets of immune checkpoint inhibitors in patients with lung cancer
Region	Japan

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

Objectives
Narrative objectives1	Pharmacodynamics (PD) of immune checkpoint inhibitors in lung cancer patients will be analyzed based on T cell subsets to evaluate their association with antitumor effects and immune-related adverse events (irAE).
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in T cell subsets
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	1) 20 years or older 2) Lung cancer patients 3) Scheduled to be treated with an immune checkpoint inhibitor. 4) Written consent has been obtained.
Key exclusion criteria	inappropriate by the investigator and the investigator
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tohru Middle name Last name Hashida
Organization	Kobe City Medical Center General Hospital
Division name	Department of pharmacy
Zip code	6500047
Address	2-1-1 Minatojima-minami-machi, Chuo-ku, Kobe
TEL	078-304-4321
Email	tohru@kcho.jp

Public contact
Name of contact person	1st name Kei Middle name Last name Irie
Organization	Kobe Gakuin University
Division name	Faculty of Pharmaceutical Science
Zip code	650-8586
Address	1-1-3 Minatojima, Chuo-ku, Kobe
TEL	078-974-1551
Homepage URL
Email	kei_irie@pharm.kobegakuin.ac.jp

Sponsor
Institute	Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe City Medical Center General Hospital
Address	2-1-1 Minatojima-minami-machi, Chuo-ku, Kobe
Tel	078-974-1551
Email	kei_irie@pharm.kobegakuin.ac.jp

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	2021 Year 03 Month 09 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	Open public recruiting
Date of protocol fixation	2020 Year 10 Month 12 Day
Date of IRB	2020 Year 10 Month 16 Day
Anticipated trial start date	2020 Year 10 Month 26 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observation study

Management information
Registered date	2021 Year 03 Month 09 Day
Last modified on	2021 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049752