UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022932 |
|---|---|
| Receipt number | 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 12:20:31 |
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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
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
akunitom@nnh.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026160
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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