UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017803 |
|---|---|
| Receipt number | 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 04:40:26 |
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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
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
h-aoki@jutendo.ac.jp
Sponsor or person
Institute
Juntendo university graduate school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020625
