UMIN-CTR Clinical Trial

Basic information
Public title	Observation of changes in comprehensive immune pathology in chemotherapy including Nivolumab for patients with refractory malignant pleural mesothelioma
Acronym	Observation of changes in comprehensive immune pathology in chemotherapy including Nivolumab for patients with refractory malignant pleural mesothelioma
Scientific Title	Observation of changes in comprehensive immune pathology in chemotherapy including Nivolumab for patients with refractory malignant pleural mesothelioma
Scientific Title:Acronym	Observation of changes in comprehensive immune pathology in chemotherapy including Nivolumab for patients with refractory malignant pleural mesothelioma
Region	Japan Asia(except Japan)

Condition
Condition	Malignant pleural mesothelioma
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Prediction of the effect of Nivolumab on malignant pleural mesothelioma Search for biomarkers
Basic objectives2	Others
Basic objectives -Others	Observation of comprehensive immune pathology before and after chemotherapy including Nivolbam is performed on exacerbating malignant pleural mesothelioma with progression and recurrence with exacerbation and at the time of judgment of efficacy in continuous treatment (or when a disease state changes) By doing so, we aim to search for biomarkers for predicting the effects of opigo in malignant pleural mesothelioma.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comprehensive station immune dynamics using peripheral blood before Bivolbam administration, 5 to 7 days after administration and after about 3 months
Key secondary outcomes	Search biomarkers after analysis

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Malignant pleural mesothelioma of unresectable progression and recurrence exacerbated after cancer chemotherapy
Interventions/Control_2	Elderly subjects with non-tumor types (including mesothelioma), non-asbestos exposure and nonimmune diseases almost agreeing with age
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	Malignant pleural mesothelioma of unresectable progression and recurrence exacerbated after cancer chemotherapy
Key exclusion criteria	Initial and resectable malignant pleural mesothelioma
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yasumitsu Middle name Last name Nishimura
Organization	Kawasaki Medical School
Division name	Department of Hygiene
Zip code	701-0192
Address	577 Mastushima, Kurashiki, Okayama, Japan
TEL	08063084002
Email	yas@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Yasumitsu Middle name Last name Nishimura
Organization	Kawasaki Medical School
Division name	Department of Hygiene
Zip code	7010192
Address	577 Mastushima, Kurashiki, Okayama, Japan
TEL	086-462-1111
Homepage URL
Email	yas@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Health labor occupational injury disease clinical research project subsidy
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kawasaki Medical School
Name of secondary funder(s)	Faculty research expenses, project research expenses

IRB Contact (For public release)
Organization	Kawasaki Medical School Ethics Committee
Address	577 Matsushima
Tel	08063084002
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	2018 Year 12 Month 01 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	2018 Year 09 Month 26 Day
Date of IRB	2018 Year 10 Month 30 Day
Anticipated trial start date	2018 Year 12 Month 01 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

Management information
Registered date	2018 Year 09 Month 28 Day
Last modified on	2020 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039118