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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017803
Receipt No. R000020625
Scientific Title Observational study about physical function, mental function and nutrition based on a comprehensive geriatric assessment to establish supportive therapy for cancer treatment on elderly patients.
Date of disclosure of the study information 2015/06/05
Last modified on 2015/06/04

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Basic information
Public title Observational study about physical function, mental function and nutrition based on a comprehensive geriatric assessment to establish supportive therapy for cancer treatment on elderly patients.
Acronym Observational study about physical function, mental function and nutrition based on a comprehensive geriatric assessment to establish supportive therapy for cancer treatment on elderly patients.
Scientific Title Observational study about physical function, mental function and nutrition based on a comprehensive geriatric assessment to establish supportive therapy for cancer treatment on elderly patients.
Scientific Title:Acronym Observational study about physical function, mental function and nutrition based on a comprehensive geriatric assessment to establish supportive therapy for cancer treatment on elderly patients.
Region
Japan

Condition
Condition Genitourinary cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1. To evaluate the reserve of genitourinary cancer in elderly patients, to perform a risk assessment of the treatment.
2. In the genitourinary cancer in elderly patients, we want to explore the predictors of treatment response.
3. In the genitourinary cancer in elderly patients, to explore the supportive therapy of cancer treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival, Healthy life expectancy
Key secondary outcomes Progression-free survival, Adverse events, Complications, Scores of various geriatric index

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. Age: 70 years old or older.
2.Tissue has been diagnosed with Prostate cancer, Urothelial cancer, and Kidney cancer.
3. Consent of the document can be obtained from the patients.
Key exclusion criteria 1. Independence walking and standing retention difficult thing.
2. Patients who does not obtained consent in writing.
3. Research investigator or research sharing doctor has determined to be inappropriate as a target.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Aoki
Organization Juntendo university graduate school of medicine
Division name urological surgery
Zip code
Address 2-1-1 Hongo Bunkyo Tokyo Japan
TEL 03-3813-3111
Email h-aoki@jutendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Aoki
Organization Juntendo university graduate school of medicine
Division name urological surgery
Zip code
Address 2-1-1 Hongo Bunkyo Tokyo Japan
TEL 03-3813-3111
Homepage URL
Email h-aoki@jutendo.ac.jp

Sponsor
Institute Juntendo university graduate school of medicine
Institute
Department

Funding Source
Organization None
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

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 05 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 Enrolling by invitation
Date of protocol fixation
2015 Year 06 Month 05 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2015 Year 06 Month 04 Day
Last modified on
2015 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020625

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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