UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054212 |
|---|---|
| Receipt number | R000061861 |
| Scientific Title | Evaluating significance of Geriatric Assessments, a multicenter Prospective Observational Study in real World diffuse large B-cell lymphoma patients of Elderly. |
| Date of disclosure of the study information | 2024/04/21 |
| Last modified on | 2024/08/09 12:19:39 |
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Basic information
Public title
Evaluating significance of Geriatric Assessments, a multicenter Prospective Observational Study in real World diffuse large B-cell lymphoma patients of Elderly.
Acronym
G-POWER
Scientific Title
Evaluating significance of Geriatric Assessments, a multicenter Prospective Observational Study in real World diffuse large B-cell lymphoma patients of Elderly.
Scientific Title:Acronym
G-POWER
Region
| Japan |
Condition
Condition
Diffuse large B-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between geriatric assessment and prognosis in elderly diffuse large B-cell lymphoma (DLBCL) patients aged 70 years and older.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of physical and physiological function decline in elderly DLBCL patients using a geriatric assessment and construction of a frailty scale.
Key secondary outcomes
Understanding the treatment outcomes in elderly DLBCL patients.
Evaluation of initial treatment conditions using the newly constructed frailty scale derived from geriatric assessments.
Assessment of the relationship between the newly constructed frailty scale from geriatric assessments and clinical outcomes.
Evaluation of the relationship between treatment intensity, clinical outcomes, and the newly constructed frailty scale from geriatric assessments.
Evaluation of the efficacy and safety of initial treatment regimens in elderly DLBCL patients.
Understanding geriatric assessments.
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients newly diagnosed with CD20 positive DLBCL as per the WHO classification (Revised 4th edition, 2017), untreated, and including those with transformed cases (pre-treatment steroid administration is permissible). The specific histological diagnoses considered in this study are:
DLBCL (NOS): Diffuse large B-cell lymphoma, not otherwise specified
THRLBCL: T-cell/histiocyte-rich large B-cell lymphoma
EBV DLBCL (NOS): EBV-positive diffuse large B-cell lymphoma, not otherwise specified
ALK(+) LBCL: ALK-positive large B-cell lymphoma
HHV8 DLBCL (NOS): HHV8-positive diffuse large B-cell lymphoma, not otherwise specified
HGBL (MYC, BCL2/6): High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
HGBL (NOS): High-grade B-cell lymphoma, not otherwise specified
(2) Patients diagnosed at the age of 70 years or older.
(3) Patients scheduled to be treated with one of the following therapies: Pola-R-CHP, R-CHOP, R-THP-COP, R-EPOCH (dosage determined by the facility and attending physician).
(4) Patients without CNS involvement.
(5) Patients from whom consent has been obtained in writing, either by the patients themselves or by their legal representatives.
(6) Asian patients.
Key exclusion criteria
(1) Patients who are judged by the principal investigator or sub-investigator to be inappropriate to participate in this study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Mamiko |
| Middle name | |
| Last name | Sakata |
Organization
University of Tsukuba Hospital
Division name
Department of Hematology
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
029-853-3293
sakatama@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Nakamura |
Organization
Gifu University Hospital
Division name
Department of Hematology and Infectious Diseases
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Gifu
TEL
058-230-6000
Homepage URL
nakamura.nobuhiko.s1@f.gifu-u.ac.jp
Sponsor or person
Institute
G-POWER Study Group
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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, University of Tsukuba Hospita
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-5876, Japan
Tel
029-853-3914
rinshokenkyu@un.tsukuba.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
国立病院機構岡山医療センター（岡山県）、藤田医科大学岡崎医療センター（愛知県）、浜松医科大学医学部附属病院（静岡県）、岐阜市民病院（岐阜県）、長崎大学病院（長崎県）、埼玉医科大学国際医療センター（埼玉県）、熊本大学病院（熊本県）、佐世保市総合医療センター（長崎県）、愛知県がんセンター（愛知県）、岐阜大学医学部附属病院（岐阜県）、岐阜赤十字病院（岐阜県）、独立行政法人国立病院機構災害医療センター（東京都）、東北大学病院（宮城県）、松波総合病院（岐阜県）、名古屋市立大学（愛知県）、都立駒込病院（東京都）、神奈川県立がんセンター（神奈川県）、愛媛大学医学部附属病院（愛媛県）、豊川市民病院（愛知県）、九州大学病院（福岡県）、京都府立医科大学附属病院（京都府）、社会医療法人 名古屋記念財団 名古屋記念病院（愛知県）、福井大学（福井県）、和歌山県立医科大学（和歌山県）、三重大学大学院医学系研究科（三重県）、名古屋大学医学部附属病院（愛知県）、海南医療センター（和歌山県）、紀南病院（和歌山県）、京都第一赤十字病院（京都府）、国立がん研究センター中央病院（東京都）、名古屋市立大学医学部附属西部医療センター（愛知県）、くまもと森都総合病院（熊本県）、国立病院機構 渋川医療センター（群馬県）、岐阜県厚生農業協同組合連合会 中濃厚生病院（岐阜県）、山梨大学医学部付属病院（山梨県）、北海道大学病院（北海道）、国立病院機構 名古屋医療センター（愛知県）、天使病院（北海道）、豊田厚生病院（愛知県）、JA愛知厚生連海南病院（愛知県）、札幌北楡病院（北海道）、宮城県立がんセンター（宮城県）、医療法人菊郷会 愛育病院（北海道）、筑波大学附属病院（茨城県）、岡山大学病院（岡山県）、公立藤岡総合病院（群馬県）、神鋼記念病院（兵庫県）、大手前病院（大阪府）、大網白里市立国保大網病院（千葉県）、茨城県厚生農業協同組合連合会 総合病院土浦協同病院（茨城県）、山形大学医学部附属病院（山形県）、医療法人恒仁会 新潟南病院（新潟県）、国立病院機構長崎医療センター（長崎県）、弘前大学医学部附属病院（青森県）、島根県立中央病院（島根県）、愛知医科大学病院（愛知県）、兵庫医科大学病院（兵庫県）、日本赤十字社高槻赤十字病院（大阪府）、徳島大学病院（徳島県）、関西医科大学附属病院（大阪府）、仙台市立病院（宮城県）、白河厚生総合病院（福島県）、東邦大学医療センター大森病院（東京都）、福岡大学医学部（福岡県）、前橋赤十字病院（群馬県）、京都第二赤十字病院（京都府）、群馬県立がんセンター（群馬県）、JCHO埼玉メディカルセンター（埼玉県）、飯塚病院（福岡県）、藤田医科大学（愛知県）、JA北海道厚生連札幌厚生病院（北海道）、広島赤十字・原爆病院（広島県）、埼玉県立がんセンター（埼玉県）、岐阜県総合医療センター（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None.
Management information
Registered date
| 2024 | Year | 04 | Month | 21 | Day |
Last modified on
| 2024 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061861
