UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of immune status of the tumor microenvironment in esophageal cancer patients treated with PD-1 blockade therapy
Acronym	PD-1 blockade therapy and immune status of the tumor microenvironment in esophageal cancer patients
Scientific Title	Accompanying research No. 2 of "Analyses of immune status in malignant tumor patients": analysis of immune status of the tumor microenvironment in esophageal cancer patients treated with PD-1 blockade therapy
Scientific Title:Acronym	Analysis of immune status of the tumor microenvironment in esophageal cancer patients treated with PD-1 blockade therapy
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the association between efficacy of PD-1 blockade therapy and immune profiling in esophageal cancer patients
Basic objectives2	Others
Basic objectives -Others	Translational research
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Association between efficacy of PD-1 blockade therapy and immune profiling
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	Esophageal patients who joined in "Analyses of immune status in malignant tumor patients" and agreed with secondary use
Key exclusion criteria	Clinicians judge as ineligible cases.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yusuke Middle name Last name Amanuma
Organization	Chiba Cancer Center
Division name	Clinical Trial Promotion Department
Zip code	260-8717
Address	666-2, Nitona-cho, Chuo-ku, Chiba
TEL	0432645431
Email	yamanuma@chiba-cc.jp

Public contact
Name of contact person	1st name Yosuke Middle name Last name Togashi
Organization	Chiba Cancer Center
Division name	Research Institute
Zip code	260-8717
Address	666-2, Nitona-cho, Chuo-ku, Chiba
TEL	0432645431
Homepage URL
Email	ytogashi@chiba-cc.jp

Sponsor
Institute	Chiba Cancer Center
Institute
Department

Funding Source
Organization	ONO PHARMACEUTICAL CO., LTD. and Bristol-Myers Squibb K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Chiba Cancer Center
Address	666-2, Nitona-cho, Chuo-ku, Chiba
Tel	0432645431
Email	rinshokenkyu@chiba-cc.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 01 Month 25 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 07 Month 29 Day
Date of IRB	2020 Year 08 Month 11 Day
Anticipated trial start date	2020 Year 12 Month 14 Day
Last follow-up date	2023 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2021 Year 01 Month 24 Day
Last modified on	2021 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=R000049220