UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054850 |
|---|---|
| Receipt number | R000061731 |
| Scientific Title | Real world treatment data of secondary central nervous system involvement in patients with large B-cell lymphoma, a multicenter retrospective Study in Japan (CONSENSUS) |
| Date of disclosure of the study information | 2024/07/08 |
| Last modified on | 2024/07/02 12:24:10 |
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Basic information
Public title
Real world treatment data of secondary central nervous system involvement in patients with large B-cell lymphoma, a multicenter retrospective Study in Japan (CONSENSUS)
Acronym
Real world treatment data of secondary central nervous system involvement in patients with large B-cell lymphoma, a multicenter retrospective Study in Japan (CONSENSUS)
Scientific Title
Real world treatment data of secondary central nervous system involvement in patients with large B-cell lymphoma, a multicenter retrospective Study in Japan (CONSENSUS)
Scientific Title:Acronym
Real world treatment data of secondary central nervous system involvement in patients with large B-cell lymphoma, a multicenter retrospective Study in Japan (CONSENSUS)
Region
| Japan |
Condition
Condition
Large B-cell lymphoma with secondary nervous system involvement
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate clinical features, treatment and efficacy of secondary central nervous system involvement in patients with large B-cell lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival of diffuse large B-cell lymphoma patients with secondary nervous system involvement diagnosed between 2012 and 2022 at participating institutes.
Key secondary outcomes
Clinical features, treatment and risk factors affecting relapse and survival in diffuse large B-cell lymphoma patients with secondary nervous system involvement diagnosed between 2012 and 2022 at participating institutes.
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 all the following criteria are eligible.
1.Patients who were histologically diagnosed with large B-cell lymphoma between January 1, 2012 and December 31, 2022.
2.Patients who have involvement of the central nervous system at either newly diagnosed or relapse.
Key exclusion criteria
Patients with one or more of the following are excluded.
1.Patients who were diagnosed primary DLBCL of the central nervous system.
2.Patients who were treated with chemotherapy or radiotherapy for previously diagnosed lymphomas other than large B-cell lymphoma.
3.Patients who refused to consent to participate this research.
4.Patients with HIV antibody positive (not excluded if HIV antibody not measured).
Target sample size
520
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Iida |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Hematology & Oncology
Zip code
467-8601
Address
1, Kawasumi Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-853-8738
iida@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Sasaki |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Hematology & Oncology
Zip code
467-8601
Address
1, Kawasumi Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-853-8738
Homepage URL
hsasaki@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Nagoya City University Graduate School of Medical Sciences
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
Clinical Research Ethics Review Committee of Nagoya City University Hospital
Address
1, Kawasumi Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel
052-851-5511
clinical_research@med.nagoya-cu.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
愛知県がんセンター 血液・細胞療法部 （愛知県）
安城更生病院 血液・腫瘍内科 （愛知県）
愛媛大学医学部附属病院 第一内科 (愛媛県)
大分県立病院 血液内科 （大分県）
大阪国際がんセンター 血液内科 （大阪府）
神奈川県立がんセンター 血液内科 （神奈川県）
金沢医科大学病院 血液・リウマチ膠原病科 （石川県）
がん研究会有明病院 血液腫瘍科 （東京都）
岐阜大学医学部附属病院 血液・感染症内科 （岐阜県）
京都第一赤十字病院 血液内科 （京都府）
京都大学 脳神経外科 （京都府）
京都府立医科大学附属病院 血液内科 （京都府）
杏林大学医学部 血液内科 （東京都）
杏林大学医学部 脳神経外科 (東京都)
熊本大学病院 血液内科 （熊本県）
群馬県立がんセンター 血液内科 （群馬県）
慶應義塾大学病院 血液内科 （東京都）
国立がん研究センター中央病院 血液腫瘍科 （東京都）
国立病院機構岡山医療センター 血液内科 (岡山県)
国立病院機構名古屋医療センター 血液内科 （愛知県）
埼玉医科大学国際医療センター 造血器腫瘍科 （埼玉県）
佐世保市総合医療センター 血液内科 （長崎県）
JA愛知厚生連海南病院 血液内科 （愛知県）
聖マリアンナ医科大学 血液・腫瘍内科 （神奈川県）
千葉県がんセンター 腫瘍・血液内科 （千葉県）
筑波大学医学医療系 血液内科 （茨城県）
東北大学病院 血液内科 （宮城県）
獨協医科大学 血液・腫瘍内科 （栃木県）
豊川市民病院 血液内科 （愛知県）
豊田厚生病院 血液内科 （愛知県）
都立駒込病院 腫瘍内科 （東京都）
長崎大学病院 血液内科 （長崎県）
名古屋市立大学病院 血液・腫瘍内科 （愛知県）
名古屋市立大学医学部附属西部医療センター 血液・腫瘍内科 （愛知県）
名古屋大学医学部附属病院 血液内科 （愛知県）
浜松医科大学 血液内科 （静岡県）
福井大学医学部附属病院 血液・腫瘍内科 （福井県）
藤田医科大学 血液内科 （愛知県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 08 | 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
520
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
| 2024 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2029 | Year | 12 | 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
| 2024 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061731
