UMIN-CTR Clinical Trial

Basic information
Public title	Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers
Acronym	Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers
Scientific Title	Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers
Scientific Title:Acronym	Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers
Region	Japan

Condition
Condition	Urological cancers (Prostate cancer: PC, bladder cancer: BC, upper tract urothelial carcinoma: UTUC, renal cell carcinoma: RCC) Controls (Ctrl) Subjects who participated in the general health survey in the IWAKI health promotion project between 2013 and 2018.
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To validate the efficacy of f frailty discriminant score (FDS) in patients with urological cancers
Basic objectives2	Others
Basic objectives -Others	Non-inferiority study
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Primary endpoint: Discrimination of Ctrl with cancer patients using FDS. Validation of FDS on cancer status between the patients with PC vs. Ctrl, and between the patients with non-PC (BC, UTUC, RCC,) vs. Ctrl. Sample size calculation for primary endpoints (http://www.biosoft.hacettepe.edu.tr/easyROC/ ver.1.3.1) The sample size for non-PC non-inferiority margin <5% AUC for standard test : 0.967 Sample size calculation for testing noninferiority of a new test to a standard test ----------------------------------------- Input: ----------------------------------------- Type I error : 0.025 Power : 0.9 AUC for standard test : 0.967 Allocation ratio : 2 ----------------------------------------- Output: ----------------------------------------- Case : 139 Control : 287 Total : 417 ----------------------------------------- The sample size for PC non-inferiority margin <5% in AUC: AUC for standard test : 0.974 ----------------------------------------- Input: ----------------------------------------- Type I error : 0.025 Power : 0.9 AUC for standard test : 0.974 Allocation ratio : 2 ----------------------------------------- Output: ----------------------------------------- Case : 102 Control : 204 Total : 306 -----------------------------------------
Key secondary outcomes	Secondary endpoints: Prognostic value Validation of FDS on prognosis prediction in urological cancer patients between the FDS-high vs. -low. FDS-high and -low were defined >2.3 in non-PC and >3.3 in PC, respectively. Sample size calculation for secondary endpoints Overall survival (OS) between the FDS-high and -low. FDS-high: FDS>2.3 in non-PC patients and >3.3 in PC patients FDS-low: FDS =<2.3 in non-PC patients and =<3.3 in PC patients Our sample size calculations were based on the primary outcome of OS. Our previous study suggested the 2-year OS in patients with FDS-high and -low were 73% and 96%, respectively. Using 90% power and 2.5% two-sided alpha, the sample size to illustrate the superiority of FDS-high and -low was 68 participants per arm (an allocation ratio 1:1, total n = 136) will be required. Accounting for 15% withdrawal/loss to follow-up, 156 (78 vs. 78) participants will need to be recruited.

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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Key inclusion criteria: 1) patients with PC, BC, UTUC, or RCC who can evaluate the frailty using FDS. 2) Agree with the frailty evaluation.
Key exclusion criteria	Key exclusion criteria: 1) patients with cancer except for PC, BC, UTUC, or RCC. 2) patients with severe general condition who could not evaluate the frailty using FDS. Controls (Ctrl)
Target sample size	926

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Hatakeyama
Organization	Hirosaki Univ.
Division name	Urology
Zip code	036-8562
Address	5 Zaifu-chou
TEL	+81172395091
Email	shingorilla2@gmail.com

Public contact
Name of contact person	1st name Shingo Middle name Last name Hatakeyama
Organization	Hirosaki Univ
Division name	Urology
Zip code	036-8562
Address	5 Zaifu-chou
TEL	+81172395091
Homepage URL
Email	shingorilla2@gmail.com

Sponsor
Institute	Hirosaki Univ. School of Med.
Institute
Department

Funding Source
Organization	Hirosaki Univ. School of Med
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Dept. of Urology, Hirosaki University Graduate School of Medicine

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hirosaki Univ. School of Med.
Address	5 Zaifu-chou
Tel	0172-33-5111
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	2019 Year 04 Month 14 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 frailty discriminant score (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. The primary outcome was the non-inferiority (margin 5%) of FDS in discriminating patients with urological cancers from controls (Ctrl).
Adverse events	none
Outcome measures	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.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 31 Day
Date of IRB	2017 Year 01 Month 06 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date	2022 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Statistical analyses of clinical data were performed using SPSS ver. 24.0 (IBM, Inc., Armonk, NY, USA), BellCurve for Excel (Social Survey Research Information Co., Ltd., Tokyo, Japan), GraphPad Prism 5.03 (GraphPad Software, San Diego, CA, USA), and R (R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/).

Management information
Registered date	2019 Year 04 Month 13 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=R000041586