UMIN-CTR Clinical Trial

Basic information
Public title	An observational validation study of the impact of Frailty on posttreatment adverse events and poor prognosis in patients with a patient with urological diseases
Acronym	An observational validation study of the impact of Frailty on posttreatment adverse events and poor prognosis in patients with a patient with urological diseases
Scientific Title	An observational validation study of the impact of Frailty on posttreatment adverse events and poor prognosis in patients with a patient with urological diseases
Scientific Title:Acronym	An observational validation study of the impact of Frailty on posttreatment adverse events and poor prognosis in patients with a patient with urological diseases
Region	Japan

Condition
Condition	Urological diseases
Classification by specialty	Nephrology Endocrine surgery Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the validity of Frailty for posttreatment adverse events and poor prognosis in patients with patient with urological diseases in multicenter setting
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Primary outcomes: Predicting frailty related post-treatment adverse events using Frailty Discriminant score Secondary outcomes: Comparison of previously reported frailty assessment tools for diagnostic accuracy for frailty, Overall survival, Cancer-specific survival, Postoperative complication, Chemotherapy related to severe adverse events, Clinical indication for definitive therapies (surgery, chemotherapy and/or radiotherapy), Relationship between frailty and quality of life
Key secondary outcomes	This study is a part of our prospective observational study (UMIN000025057). We planned the inter-group difference of frailty among the patients with prostate cancer (PC), renal cell carcinoma (RCC), and urothelial carcinoma (UC) when we successfully developed our CGA tool.

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	Patients with urological diseases who undergo frailty assessments. Urological diseases include both malignant and non-malignant diseases.
Key exclusion criteria	Patients with urological diseases who could not undergo frailty assessments.
Target sample size	600

Research contact person
Name of lead principal investigator	1st name SHINGO Middle name Last name Hataeyama
Organization	Hirosaki University
Division name	Urology
Zip code	036-8562
Address	5 zaifu
TEL	0172395091
Email	shingorilla2@gmail.com

Public contact
Name of contact person	1st name SHINGO Middle name Last name Hatakeyama
Organization	Hirosaki University Graduate School of Medicine
Division name	Urology
Zip code	0368562
Address	5 zaifu
TEL	0172395091
Homepage URL
Email	shingorilla2@gmail.com

Sponsor
Institute	Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Government offices of other countries
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

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 06 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/31520152/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/31520152/
Number of participants that the trial has enrolled	559
Results	The FDS is a reliable and valid tool for assessing frailty and prognosis in patients with urological cancers.
Results date posted	2022 Year 12 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	We prospectively validate the efficacy of the frailty discriminant score (FDS) in individuals with urological cancers, as there has been growing importance in evaluating frailty in clinical practice.
Participant flow	A prospective, multicenter study was conducted from February 2017 to April 2019. We enrolled 258 patients with urological cancers and 301 community-dwelling participants who were assessed for frailty. Frailty was assessed using FDS that includes ten items, such as physical, mental, and blood biochemical tests.
Adverse events
Outcome measures	The primary outcome was the non-inferiority (margin 5%) of FDS in discriminating patients with urological cancers from controls (Ctrl). The sensitivity, specificity, and area under the receiver operating characteristic (AUROC) curve for each predictive test were calculated. The secondary endpoints included the prediction of overall survival between patients with urological cancer who have high and low FDS. FDS was significantly higher in patients with urological cancers than that in the Ctrl.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 01 Day
Date of IRB	2016 Year 01 Month 06 Day
Anticipated trial start date	2017 Year 07 Month 02 Day
Last follow-up date	2022 Year 07 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study is an observational prospective validation study of the impact of Frailty Discriminant score on post-treatment adverse events and poor prognosis in patients with patient with urological diseases in multicenter setting. Patients in this study undergo frailty assessment including G8, gait speed, handgrip strength, fatigue and depression questionnaire, and basic blood biochemical test. Frailty Discriminant score were calculated, and outcomes are prospectively evaluated. Study interval is estimated for 5 years.

Management information
Registered date	2017 Year 08 Month 04 Day
Last modified on	2022 Year 12 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032653