UMIN-CTR Clinical Trial

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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