UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025231 |
|---|---|
| Receipt number | R000028882 |
| Scientific Title | Comprehensive Geriatric Assessment study to determine an appropriate therapy for elderly patients with diffuse large B-cell lymphoma |
| Date of disclosure of the study information | 2016/12/12 |
| Last modified on | 2022/06/16 11:05:45 |
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Basic information
Public title
Comprehensive Geriatric Assessment study to determine an appropriate therapy for elderly patients with diffuse large B-cell lymphoma
Acronym
CGAL study
Scientific Title
Comprehensive Geriatric Assessment study to determine an appropriate therapy for elderly patients with diffuse large B-cell lymphoma
Scientific Title:Acronym
CGAL study
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
Purpose of the study is to evaluate comprehensive geriatric assessment and to find the risk factors and establish a scoring system to predict severe complications in association with treatment for the elderly patients with diffuse large B-cell lymphoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between CGA results and treatment outcomes(G3,4,5 adverce events)
Key secondary outcomes
1)Average relative dose intensity (ARDI)
2)Treatment completion rate
3)Complete response (CR)
4)Event-free survival(EFS)
5)Overall survival (OS)
6)Cause of death
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Newly-diagnosed untreated patient with histologically-proven DLBCL
A patient who gives an informed consent to participate in this study
Key exclusion criteria
A patient who is judged inadequate for this study by his/her physician
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Takamatsu |
Organization
Fukuoka University
Division name
Division of Medical Oncology, Hematology and Infectious Disease
Zip code
814-0180
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
yasushi@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Tamura |
Organization
Fukuoka University
Division name
Division of Medical Oncology, Hematology and Infectious Disease
Zip code
814-0180
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
Homepage URL
ktamura@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Division of Medical Oncology, Hematology and Infectious Disease
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University Hospital Clinical Research Assist Center
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka
Tel
092-801-1011
kenji0715@adm.fukuoka-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
福岡大学病院（福岡県）、九州がんセンター（福岡県）、産業医科大学病院（福岡県）、神奈川県立がんセンター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
84 patients have been registered and the results of MNA,CCI, ADL, IADL, HDS-R,and VES-13 have been collected and will be put into the computer to analyze.
Management information
Registered date
| 2016 | Year | 12 | Month | 12 | Day |
Last modified on
| 2022 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028882
| 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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| Registered date | File name |
