UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027729
Receipt number 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 15:52:59

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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 or person

Institute

Cancer Center, Osaka Medical College

Institute

Department

Personal name



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

Value
https://center6.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