UMIN-CTR Clinical Trial

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
Email	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
Email	shingoh@hirosaki-u.ac.jp

Sponsor
Institute	Dept. of Urology, Hirosaki University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028835