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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035834
Receipt No. R000040820
Official scientific title of the study Prospective observational study of simplified geriatric assessment in elderly patients with hematologic diseases
Date of disclosure of the study information 2019/02/10
Last modified on 2019/02/10

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Basic information
Official scientific title of the study Prospective observational study of simplified geriatric assessment in elderly patients with hematologic diseases
Title of the study (Brief title) simplified GA
Region
Japan

Condition
Condition Hematologic diseases
Classification by specialty
Hematology and clinical oncology Geriatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the clinical significance of simplified geriatric assessment in elderly patients with hematologic diseases.
Basic objectives2 Others
Basic objectives -Others To assess the relationship between simplified GA and prognosis.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The relationship between simplified GA and prognosis.
Key secondary outcomes Overall survival(OS)
Progression free survival(PFS)
Early mortality
Response rate
Adverse event
Treatment

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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with histologically-confirmed hematologic disease
2)Patients who received informed consent
3)>=60 years old
4)Written informed consent form prior to participation in the study
Key exclusion criteria 1)Ptients with consciousness disturbance
2)Patients with severe physical dysfunction
3)Patients with severe mental disorder
4)Patients with pacemaker
Target sample size 120

Research contact person
Name of lead principal investigator Tomonori Nakazato
Organization Yokohama Municipal Citizen's Hospital
Division name Department of Hematology
Address 56 Okazawa-cho, Hodogaya-ku, Yokohama 240-8555, Japan.
TEL 045-331-1961
Email n-tomo@eurus.dti.ne.jp

Public contact
Name of contact person Tomonori Nakazato
Organization Yokohama Municipal Citizen's Hospital
Division name Department of Hematology
Address 56 Okazawa-cho, Hodogaya-ku, Yokohama 240-8555, Japan
TEL 045-331-1961
Homepage URL
Email n-tomo@eurus.dti.ne.jp

Sponsor
Institute Department of Hematology
Yokohama Municipal Citizen's Hospital
Institute
Department

Funding Source
Organization Department of Hematology
Yokohama Municipal Citizen's Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 10 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 30 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information As prospective observational study, 1)-10) are conducted at the beginning of the study.
1)G8
2)IADL
3)Mini-Cog
4)CCI
5)Body composition analysis (BIA)
6)Short Physical Performance Battery(SPPB)
7)Grip strength
8)BMI
9)PS
10)Advanced Glycation Endproducts(AGEs)

Management information
Registered date
2019 Year 02 Month 10 Day
Last modified on
2019 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040820

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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