UMIN-CTR Clinical Trial

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
Email	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
Email	ktamura@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University Division of Medical Oncology, Hematology and Infectious Disease
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028882