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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034089
Receipt No. R000038863
Scientific Title Development of prediction model for the efficacy of anti-PD-1 antibody on malignant pleural mesothelioma
Date of disclosure of the study information 2018/10/15
Last modified on 2018/09/11

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Basic information
Public title Development of prediction model for the efficacy of anti-PD-1 antibody on malignant pleural mesothelioma
Acronym Prediction model in MPM
Scientific Title Development of prediction model for the efficacy of anti-PD-1 antibody on malignant pleural mesothelioma
Scientific Title:Acronym Prediction model in MPM
Region
Japan

Condition
Condition Malignant pleural mesothelioma
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to develop a prediction model for the effect of anti-PD-1 antibody by analyzing immunocompetent cells in patients with malignant pleural mesothelioma undergoing nivolumab therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tumor response rate
Key secondary outcomes Progression Free Survival
Overall survival

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 Patients who have been confirmed as MPM by histology or cytology. (Epithelial type, sarcoma type and bilayer type are not limited)
2 MPM patients who received previous platinum agent and pemetrexede combination therapy and were judged as progressive disease.
3 Patients with at least one measurable lesion as defined by mRECIST using CT or MRI
4 Patients who can receive nivolumab therapy
5 Patients who received full explanation from investigators or research sharing doctors regarding contents of this research using agreement document and explanation document and who consented to participate in this research by the person himself or herself
Key exclusion criteria 1 Patients receiving pervious systemic chemotherapies (two or more regimens), including platinum agent and pemetrexede combination therapy.
2 Patients with ECOG PS 2 or more
3 Patients receiving steriod therapy (10mg per day or more)
4 Patients receiving antibiotics between 4 weeks before and after the nivolumab therapy
5 Patients who are deemed inappropriate as study participants by investigators or medical doctors.





























Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiki Hasegawa
Organization Hyogo college of medicine
Division name Department of Thoracic Surgery
Zip code
Address 1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.
TEL 0798-45-6111
Email hasegawa@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiji Matsumoto
Organization Hyogo college of medicine
Division name Department of Thoracic Surgery
Zip code
Address 1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.
TEL 0798-45-6111
Homepage URL
Email smatsumo@hyo-med.ac.jp

Sponsor
Institute Hyogo college of medicine
Institute
Department

Funding Source
Organization Hyogo college of medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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 10 Month 15 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 18 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Tumor immune escape mechanism has recently been elucidated. Anti-tumor immunity antibodies are attracting attention. As susceptibility predictors of antitumor immune antibodies, tumor and lymphocyte antigens and expression of surface markers can be mentioned, but little is known regarding these issues. The objectives of this study are as follows.
1 Development of prediction method for the efficacy of antitumor immune antibody by receptor analysis of lymphocytes and measurement of expression of surface markers
2 Correlation between PD-L1 expression and tumor mutation burden using tumor specimens and lymphocyte analysis results
3 Neoepitope analysis using tumor and normal tissue
4 Correlation between intestinal and oral cavity flora, lymphocyte immune cell receptor and efficacy of anti-PD1 antibody















Management information
Registered date
2018 Year 09 Month 11 Day
Last modified on
2018 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038863

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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