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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022932
Receipt No. R000026160
Scientific Title Multicenter cohort study on the relation between soluble PD-L1 and prognosis of age-related EBV-associated lymphoproliferative disorders.
Date of disclosure of the study information 2016/07/15
Last modified on 2018/07/03

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Basic information
Public title Multicenter cohort study on the relation between soluble PD-L1 and prognosis of age-related EBV-associated lymphoproliferative disorders.
Acronym The relation between soluble PD-L1 and prognosis of age-related EBV-associated lymphoproliferative disorders
Scientific Title Multicenter cohort study on the relation between soluble PD-L1 and prognosis of age-related EBV-associated lymphoproliferative disorders.
Scientific Title:Acronym The relation between soluble PD-L1 and prognosis of age-related EBV-associated lymphoproliferative disorders
Region
Japan

Condition
Condition EBV-associated diffuse large B-cell lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elucidate whether soluble PD-L1 is a prognostic factor in EBV-associated lymphoproliferative disorders (EBV-LPD).
Basic objectives2 Others
Basic objectives -Others To elucidate whether soluble PD-L1 correlate with overall survival in EBV-LPD.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To determine the relation between soluble PD-L1 and IPI in EBV-associated LPD.
Key secondary outcomes

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 1) The cases were diagnosed as DLBCL, which is defined by WHO classification 4th ed. 2008 and which is EBER positive using immunostaining.
2) 15 samples were prepared for central review by a pathologist.
3) The patients voluntarily gave written consent to participate in the study.
Key exclusion criteria The cases were diagnosed as immunodeficiency-associated lymphoproliferative disorders, which are defined by WHO classification 4th ed. 2008.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akane Kunitomi
Organization National Hospital Organization Nagoya Medical Center
Division name Department of Hematology
Zip code
Address 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi
TEL 052-951-1111
Email akunitom@nnh.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akane Kunitomi
Organization National Hospital Organization Nagoya Medical Center
Division name Department of Hematology
Zip code
Address 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi
TEL 052-951-1111
Homepage URL
Email akunitom@nnh.hosp.go.jp

Sponsor
Institute National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
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
2016 Year 07 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 No longer recruiting
Date of protocol fixation
2016 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 15 Day
Last follow-up date
2018 Year 05 Month 15 Day
Date of closure to data entry
2018 Year 05 Month 15 Day
Date trial data considered complete
2018 Year 05 Month 23 Day
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information none

Management information
Registered date
2016 Year 06 Month 28 Day
Last modified on
2018 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026160

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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