UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049460 |
|---|---|
| Receipt number | R000056244 |
| Scientific Title | A multi-institutional observational study of newly-diagnosed CD5-positive diffuse large B-cell lymphoma after the introduction of new therapies in Japan |
| Date of disclosure of the study information | 2022/11/09 |
| Last modified on | 2024/03/11 17:43:17 |
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Basic information
Public title
A multi-institutional observational study of newly-diagnosed CD5-positive diffuse large B-cell lymphoma after the introduction of new therapies in Japan
Acronym
CD5+ DLBCL new-era project
Scientific Title
A multi-institutional observational study of newly-diagnosed CD5-positive diffuse large B-cell lymphoma after the introduction of new therapies in Japan
Scientific Title:Acronym
CD5+ DLBCL new-era project
Region
| Japan |
Condition
Condition
CD5-positive diffuse large B-cell lymphoma (CD5+ DLBCL)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the clinical features and current status of treatment in CD5+ DLBCL patients in Japan
To evaluate the safety and efficacy of DA-EPOCH-R combined with high-dose methotrexate (PEARL5) for newly-diagnosed CD5+ DLBCL in clinical practice
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival of patients with newly-diagnosed CD5+ DLBCL in 2016-2021 at participating institutes
Key secondary outcomes
1. Clinical features, treatment, toxicity profile, and risk factors affecting survival of CD5+ DLBCL patients in 2016-2021 at participating institutes
2. Efficacy and safety of PEARL5 therapy for CD5+ DLBCL in clinical practice compared with the results of PEARL5 study
3. Efficacy of PEARL5 therapy for CD5+ DLBCL in clinical practice compared with the results of our previous retrospective study (CD5+ DLBCL R-era project)
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
Patients who meet either 1 or 2 below are eligible.
1. Patients who were diagnosed as newly-diagnosed with DLBCL, not otherwise specified (WHO classification) between January 1, 2016 and December 31, 2021 at participating institutions
2. DLBCL cells are confirmed to be CD5-positive by flow cytometry and/or immunohistochemistry.
Key exclusion criteria
Patients with one or more of the following are excluded.
1. Patients who were diagnosed as not CD5+ DLBCL based on diagnosis-related information
2. Patients who refused to consent to opt-out
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Yamaguchi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Hematological Malignancies
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-9072
myamaguchi@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Yamaguchi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Hematological Malignancies
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-9072
Homepage URL
myamaguchi@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
Tel
059-231-5045
kk-sien@mo.medic.mie-u.ac.jp
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
東北大学病院（宮城県）
群馬大学医学部附属病院（群馬県）
国立病院医機構渋川医療センター（群馬県）
公立藤岡総合病院（群馬県）
埼玉医科大学国際医療センター（埼玉県）
埼玉医科大学総合医療センター（埼玉県）
がん研究会有明病院（東京都）
杏林大学（東京都）
神奈川県立がんセンター（神奈川県）
聖マリアンナ医科大学（神奈川県）
新潟大学大学院医歯学総合研究科（新潟県）
金沢医科大学（石川県）
福井大学医学部附属病院（福井県）
岐阜大学医学部附属病院（岐阜県）
藤田医科大学岡崎医療センター（愛知県）
名古屋市立大学病院（愛知県）
愛知医科大学病院（愛知県）
豊田厚生病院（愛知県）
三重大学大学院医学系研究科（三重県）
京都大学大学院医学研究科（京都府）
大阪市立総合医療センター（大阪府）
兵庫県立がんセンター（兵庫県）
神鋼記念病院（兵庫県）
島根大学医学部附属病院（島根県）
国立病院機構岡山医療センター（岡山県）
公立学校共済組合中国中央病院（広島県）
愛媛県立中央病院（愛媛県）
九州大学大学院医学研究院（福岡県）
国立病院機構九州がんセンター（福岡県）
長崎大学病院（長崎県）
佐世保市総合医療センター（長崎県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 09 | 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
| 2022 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2022 | Year | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056244
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| Registered date | File name |
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