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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025231
Receipt No. 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 2016/12/12

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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
Middle name
Last name Yasushi Takamatsu
Organization Fukuoka University
Division name Division of Medical Oncology, Hematology and Infectious Disease
Zip code
Address 7-45-1, Nanakuma, Jonan-ku, Fukuoka
TEL 092-801-1011
Email yasushi@chotsg.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Tamura
Organization Fukuoka University
Division name General Medical Research Center
Zip code
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
Address
Tel
Email

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 No longer recruiting
Date of protocol fixation
2013 Year 07 Month 10 Day
Date of IRB
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
2016 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028882

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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