UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046477 |
|---|---|
| Receipt number | R000053029 |
| Scientific Title | Observational study to elucidate clinical and biological characteristics of DLBCL in AYA using registry data (NHO-DLBCL-AYA study). |
| Date of disclosure of the study information | 2021/12/25 |
| Last modified on | 2022/07/09 21:56:49 |
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Basic information
Public title
Observational study to elucidate clinical and biological characteristics of DLBCL in AYA using registry data (NHO-DLBCL-AYA study).
Acronym
NHOH-AYA-DLBCL
Scientific Title
Observational study to elucidate clinical and biological characteristics of DLBCL in AYA using registry data (NHO-DLBCL-AYA study).
Scientific Title:Acronym
NHOH-DLBCL-AYA
Region
| Japan |
Condition
Condition
Diffuse large B-cell lymphoma (DLBCL)
Primary mediastinal large B-cell lymphoma (PMBL)
Burkitt lymphoma (BL)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the clinical and biological features of DLBCL patients in AYA (16-39 years).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival of DLBCL patients in AYA
Key secondary outcomes
Analysis of biological features of DLBCL in AYA by integrating with clinical information and pathological and genetic features.
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
| 16 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were newly diagnosed as DLBCL, PMBL, BL based on WHO classification 2008 or WHO classification 2016 are eligible.
Key exclusion criteria
Patients who withdraw registration to this study are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Suzuki |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Hematology
Zip code
460-0001
Address
4-1-1, Sannomaru, Naka-ku, Nagoya, Japan
TEL
052-951-1111
yassuzuki@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Suzuki |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Hematology
Zip code
460-0001
Address
4-1-1, Sannomaru, Naka-ku, Nagoya, Japan
TEL
052-951-1111
Homepage URL
yassuzuki@med.nagoya-u.ac.jp
Sponsor or person
Institute
Clinical Hematology Study Group of 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
National Hospital Organization Clinical Research Central Ethics Review Board
Address
2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5050
700-kenkyu@mail.hosp.go.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
国立病院機構 北海道がんセンター（北海道）
国立病院機構 仙台医療センター（宮城県）
国立病院機構 水戸医療センター（茨城県）
国立病院機構 渋川医療センター（群馬県）
国立病院機構 東京医療センター（東京都）
国立病院機構 災害医療センター（東京都）
国立病院機構 まつもと医療センター（長野県）
国立病院機構 敦賀医療センター（福井県）
国立病院機構 あわら病院（福井県）
国立病院機構 姫路医療センター（兵庫県）
国立病院機構 米子医療センター（鳥取県）
国立病院機構 岡山医療センター（岡山県）
国立病院機構 呉医療センター（広島県）
国立病院機構 広島西医療センター（広島県）
国立病院機構 四国がんセンター（愛媛県）
国立病院機構 小倉医療センター（福岡県）
国立病院機構 九州がんセンター（福岡県）
国立病院機構 九州医療センター（福岡県）
国立病院機構 福岡東医療センター（福岡県）
国立病院機構 長崎医療センター（長崎県）
国立病院機構 熊本医療センター（熊本県）
国立病院機構 熊本南病院（熊本県）
国立病院機構 鹿児島医療センター（鹿児島県）
国立病院機構 名古屋医療センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 25 | 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
| 2021 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study (a prospective cohort study)
Management information
Registered date
| 2021 | Year | 12 | Month | 25 | Day |
Last modified on
| 2022 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053029
