UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of tumor immune microenvironments and host immune responses in cancer patients
Acronym	Analysis of tumor immune microenvironments and host immune responses
Scientific Title	Analysis of tumor immune microenvironments and host immune responses in cancer patients
Scientific Title:Acronym	Analysis of tumor immune microenvironments and host immune responses
Region	Japan

Condition
Condition	malignancy
Classification by specialty	Medicine in general Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	analysis of tumor immune microenvironment and host immune responses against cancer antigen in cancer patients
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Investigation of methods and biomarker for the prognosis of malignacy using immune factors
Key secondary outcomes	1)prospective analysis of tumor immune microenvironmens and host immune responses : os,pfs,rr 2)investigation of methods and biomarker for the prognosis of malignacy using immune factors: os,pfs,rr

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.ECOG performance status 0-2 2.Under the hematological toxicity of Grade3
Key exclusion criteria	Sever complications
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Mikio Middle name Last name Oka
Organization	Kawasaki Medical School
Division name	Department of Immuno-Oncology
Zip code	701-0192
Address	577 Matsusima, Kurashiki
TEL	086-462-1111
Email	resp@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Koji Middle name Last name Kurose
Organization	Kawasaki Medical School
Division name	Respiratory Medicine
Zip code	701-0192
Address	577 Matsusima, Kurashiki
TEL	086-462-1111
Homepage URL
Email	kuro-ko.66@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	IRB of Kawasaki Medical School
Address	577 Matsushima, Kurashiki, Okayama
Tel	086-462-1111
Email	kmsrec@med.kawasaki-m.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	2015 Year 03 Month 02 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	2015 Year 04 Month 13 Day
Date of IRB	2015 Year 04 Month 13 Day
Anticipated trial start date	2015 Year 04 Month 13 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry	2023 Year 03 Month 31 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information	prospective analysis of tumor immune microenvironmens and host immune responses : os,pfs,rr investigation of methods and biomarker for the prognosis of malignacy using immune factors: os,pfs,rr

Management information
Registered date	2015 Year 03 Month 02 Day
Last modified on	2021 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019355