UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025057 |
|---|---|
| Receipt number | R000028835 |
| Scientific Title | An observational study evaluating prevalence of frailty in patients with urological disease (FRAURO study) |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2022/12/05 22:15:33 |
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Basic information
Public title
An observational study evaluating prevalence of frailty in patients with urological disease (FRAURO study)
Acronym
An observational study evaluating prevalence of frailty in patients with urological disease (FRAURO study)
Scientific Title
An observational study evaluating prevalence of frailty in patients with urological disease (FRAURO study)
Scientific Title:Acronym
An observational study evaluating prevalence of frailty in patients with urological disease (FRAURO study)
Region
| Japan |
Condition
Condition
Urological diseases
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This is an observational study evaluating the frailty in patients with urological disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of frailty among the patients with urological cancers and develop a Comprehensive Geriatric Assessment (CGA) tool.
Key secondary outcomes
The clinical implication of frailty on outcomes including treatment outcomes. The effect of this biological-expected life age discrepancy on overall survival was retrospectively evaluated using patients in the previous study.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Males and females, 20 years or older, with urological disease who visit Hirosaki University Hospital.
Key exclusion criteria
Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of questionnaire or frail measurements.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | SHINGO |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University Hospital
Division name
Dept. of Urology
Zip code
0368562
Address
53 Honchou, Hirosaki
TEL
0172-39-5091
shingoh@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University Hospital
Division name
Dept. of Urology
Zip code
0368562
Address
53 Honchou, Hirosaki
TEL
0172-39-5091
Homepage URL
shingoh@hirosaki-u.ac.jp
Sponsor or person
Institute
Dept. of Urology, Hirosaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Dept. of Urology, Hirosaki University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University School of Medicine
Address
5 Zaifu-chou
Tel
+81172395091
rinri@hirosaki-u.ac.jp
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
弘前大学病院（青森県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1035
Results
We developed a quantitative and comprehensive geriatric assessment tool (frailty discriminant score: FDS), including 10 items, and reported the utility of this tool for treatment selection and prognosis. Also, we investigated frailty-based biological ages using FDS and found the age discrepancy between the biological and expected life ages of >5 years was also significantly associated with poor overall survival in patients with urological cancers.
Results date posted
| 2021 | Year | 06 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We included 405, 466, and 164 patients that have been diagnosed with prostate cancer, urothelial carcinoma, and renal cell carcinoma, respectively.
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We conducted this multicenter study following the Declaration of Helsinki.
This study included patients in the previous study (a prospective observational study of "Relationship between slow gait speed and postoperative delirium in elderly patients" UMIN000016210) as a retrospective cohorts
Management information
Registered date
| 2016 | Year | 11 | Month | 29 | Day |
Last modified on
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028835
