UMIN-CTR Clinical Trial

Basic information
Public title	Clinical significance of peripheral blood CD4+ T cell subpopulations for immune checkpoint inhibitor treatment
Acronym	peripheral blood CD4+ T cell subpopulations for immune checkpoint inhibitor treatment
Scientific Title	Clinical significance of peripheral blood CD4+ T cell subpopulations for immune checkpoint inhibitor treatment
Scientific Title:Acronym	peripheral blood CD4+ T cell subpopulations for immune checkpoint inhibitor treatment
Region	Japan

Condition
Condition	Patients with gastrointestinal, hepatobilial, urological, or otorhinolaryngological cancer treated with an immune chekpoint inhibitor
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery Hepato-biliary-pancreatic surgery Oto-rhino-laryngology Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify whether baseline peripheral blood CD4+ T cell subpopulations could be a therapeutic predictor for patients treated with innume checkpoint inhibitors
Basic objectives2	Others
Basic objectives -Others	To investigate the relationship between the T cell subpopulations and adverse events
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	overall survival
Key secondary outcomes	progression-free survival objective response rate adverse events during the treatment

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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	patients whom written informed consents of the study are obtained from
Key exclusion criteria	patients with past history of an immune checkpoint inhibitor
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Yoshimichi Middle name Last name Haruna
Organization	Osaka General Medical Center
Division name	Department of Laboratory Medicine
Zip code	558-8558
Address	3-1-56 Bandaihigashi, Sumiyoshiku, Osaka
TEL	06-6692-1201
Email	apple-123-grape@ab.auone-net.jp

Public contact
Name of contact person	1st name Yoshimichi Middle name Last name Haruna
Organization	Osaka General Medical Center
Division name	Department of Laboratory Medicine
Zip code	558-8558
Address	3-1-56 Bandaihigashi, Sumiyoshiku, Osaka
TEL	06-6692-1201
Homepage URL
Email	apple-123-grape@ab.auone-net.jp

Sponsor
Institute	Osaka General Medical Center
Institute
Department

Funding Source
Organization	Osaka General Medical Center
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	Osaka General Medical Center
Address	3-1-56 Bandaihigashi, Sumiyoshiku, Osaka
Tel	06-6692-1201
Email	kenkyusien@gh.opho.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	2020 Year 09 Month 20 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	2020 Year 08 Month 27 Day
Date of IRB	2020 Year 09 Month 02 Day
Anticipated trial start date	2020 Year 09 Month 10 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Forty patients will be investigated in each group of gastrointestinal and hepatobilial cancers, urological cancers or otorhinolaryngological cancers.

Management information
Registered date	2020 Year 09 Month 15 Day
Last modified on	2020 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047712