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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034312
Receipt No. R000039118
Scientific Title Observation of changes in comprehensive immune pathology in chemotherapy including Nivolumab for patients with refractory malignant pleural mesothelioma
Date of disclosure of the study information 2018/12/01
Last modified on 2018/09/28

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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
Middle name
Last name Takemi Otsuki
Organization Kawasaki Medical School
Division name Department of Hygiene
Zip code
Address 577 Mastushima, Kurashiki, Okayama, Japan
TEL 086-462-1111
Email takemi@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takemi Otsuki
Organization Kawasaki Medical School
Division name Department of Hygiene
Zip code
Address 577 Mastushima, Kurashiki, Okayama, Japan
TEL 086-462-1111
Homepage URL
Email takemi@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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
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
2018 Year 09 Month 28 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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