UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of the expression of PD-L1 in primary central nervous system lymphoma (PCNSL) tumor cells and surrounding normal tissue
Title of the study (Brief title)	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	Shin-Ichi Miyatake
Organization	Osaka Medical College
Division name	Cancer Center
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	Shin-Ichi Miyatake
Organization	Osaka Medical College
Division name	Cancer Center
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

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 07 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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