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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027729
Receipt No. R000031766
Scientific Title Analysis of the expression of PD-L1 in primary central nervous system lymphoma (PCNSL) tumor cells and surrounding normal tissue
Date of disclosure of the study information 2017/07/04
Last modified on 2017/06/12

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Basic information
Public title Analysis of the expression of PD-L1 in primary central nervous system lymphoma (PCNSL) tumor cells and surrounding normal tissue
Acronym PD-L1 expression in PCNSL
Scientific Title Analysis of the expression of PD-L1 in primary central nervous system lymphoma (PCNSL) tumor cells and surrounding normal tissue
Scientific Title:Acronym PD-L1 expression in PCNSL
Region
Japan

Condition
Condition Primary central nervous system malignant lymphoma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish the biomarker for the effectiveness of anti-PD-1 antibody for PCNSL, we analyze the expression of PD-L1 in PCNSL tumor cells and surrounding normal tissue, using needle and open biopsy specimen.
Basic objectives2 Others
Basic objectives -Others Observational study for the purpose 1
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Analysis of the expression of PD-L1 in PCNSL tumor cells and surrounding normal tissue
Key secondary outcomes Analysis of the expression of PD-L2 in PCNSL tumor cells and surrounding normal tissue and correlation between these expression and overall survival of the patients

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria PCNSL cases diagnosed from January 1, 2000, to December 31, 2016
Key exclusion criteria Insufficient material volume of surrounding normal tissues for immunohistochemistry
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-Ichi Miyatake
Organization Osaka Medical College
Division name Cancer Center
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka 569-8686
TEL 072-683-1221
Email neu070@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin-Ichi Miyatake
Organization Osaka Medical College
Division name Cancer Center
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka 569-8686
TEL 072-683-1221
Homepage URL
Email neu070@osaka-med.ac.jp

Sponsor
Institute Cancer Center, Osaka Medical College
Institute
Department

Funding Source
Organization Ono Pharmaceutical Co.,Ltd.
Bristol-Myers Squibb K.K.
(Financial sponsor only for PD-L1
expression analysis)
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor NAGOYA UNIVERSITY,OKAYAMA UNIVERSITY,
OSAKA UNIVERSITY,KANAZAWA UNIVERSITY,
FUKUI UNIVERSITY
Name of secondary funder(s) contract research fund

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 大阪医科大学附属病院(大阪府)、名古屋大学医学部附属病院(愛知県),岡山大学病院(岡山県),大阪大学医学部附属病院(大阪府),金沢大学附属病院(石川県),福井大学医学部附属病院(福井県)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 04 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
2017 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 03 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information Retrospective observational clinical study

Management information
Registered date
2017 Year 06 Month 12 Day
Last modified on
2017 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031766

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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