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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Genitourinary cancer | |
Classification by specialty |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Prospective observational study |
Management information | |||||||
Registered date |
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Last modified on |
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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 |