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
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
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
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
