UMIN-CTR Clinical Trial

Basic information
Public title	An observational study of the effect of frailty on the selection of a type of urinary diversion in patients with muscle-invasive bladder cancer: FRAUD study
Acronym	An observational study of the effect of frailty on the selection of a type of urinary diversion in patients with muscle-invasive bladder cancer: FRAUD study
Scientific Title	An observational study of the effect of frailty on the selection of a type of urinary diversion in patients with muscle-invasive bladder cancer: FRAUD study
Scientific Title:Acronym	An observational study of the effect of frailty on the selection of a type of urinary diversion in patients with muscle-invasive bladder cancer: FRAUD study
Region	Japan

Condition
Condition	Urinary bladder cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the association of the frailty with urinary diversion after radical cystectomy (RC) in patients with muscle-invasive bladder cancer (MIBC).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary purpose was the effect of frailty on urinary diversion selection after radical cystectomy (RC) in patients with muscle-invasive bladder cancer (MIBC).
Key secondary outcomes	Secondary purposes included the association of frailty on complications and the effect of frailty on overall survival.

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	Localized muscle-invasive bladder cancer patients who underwent radical cystectomy and urinary diversion
Key exclusion criteria	1) Localized muscle-invasive bladder cancer patients who do not undergo radical cystectomy and urinary diversion, and 2) who do not undergo frailty assessments.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Hatakeyama
Organization	Dept. of Urology, Hirosaki University Graduate School of Medicine
Division name	Urology
Zip code	036-8562
Address	5 Zaifu-chou, Hirosaki
TEL	0172395091
Email	shingoh@hirosaki-u.ac.jp

Public contact
Name of contact person	1st name Shingo Middle name Hatakeyama Last name Hatakeyama
Organization	Dept. of Urology, Hirosaki University Graduate School of Medicine
Division name	Urology
Zip code	036-8562
Address	5 Zaifu-chou, Hirosaki
TEL	0172395091
Homepage URL
Email	shingoh@hirosaki-u.ac.jp

Sponsor
Institute	Dept. of Urology, Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Dept. of Urology, Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	N/A = Not Applicable

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

IRB Contact (For public release)
Organization	Dept. of Urology, Hirosaki University Graduate School of Medicine
Address	Hirosaki
Tel	0172395091
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	2020 Year 01 Month 08 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/32452113/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/32452113/
Number of participants that the trial has enrolled	88
Results	Frailty is significantly associated with the type of urinary diversion, and it should be considered for the selection of urinary diversion in muscle-invasive bladder cancer patients undergoing radical cystectomy.
Results date posted	2022 Year 12 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	To investigate the effect of frailty on the type of urinary diversion after radical cystectomy in patients with muscle-invasive bladder cancer.
Participant flow	Between January 2014 and January 2020, we prospectively evaluated frailty in 88 patients with localized muscle-invasive bladder cancer, who had received radical cystectomy and urinary diversion. The selection of the type of urinary diversion was determined by the operating surgeon based on performance status, comorbidities, tumor status and the patient's preference. The frailty evaluation included the Fried phenotype criteria, the modified frailty index and the frailty discriminant score.
Adverse events	none
Outcome measures	We investigated the association between frailty and type of urinary diversion, the effect of frailty on postoperative complications and the effect of frailty on overall survival.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 06 Day
Date of IRB	2017 Year 01 Month 06 Day
Anticipated trial start date	2017 Year 01 Month 06 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

This study is a retrospective analysis of our prospective observational study (UMIN000025057). We planned to assess the intra-group difference of frailty among the patients with prostate cancer (PC), renal cell carcinoma (RCC), and urothelial carcinoma (UC) after the development of the CGA tool. In the UC cohort, we planned to evaluate 1) the intra-group difference of frailty among the different stages and treatments, the effect of frailty on safety and oncological outcomes 2) between the radical cystectomy and trimodal therapy in patients with MIBC (FRART-UC study), 3) between the neobladder and non-neobladder in patients with MIBC (FRAUD study), 4) in patients with upper tract urothelial carcinoma (FRAUT study), 5) metastatic urothelial carcinoma who underwent systemic chemotherapy and/or immunotherapy (FRAM-UC study), and 6) the association of baseline frailty and quality of life (FRAQ-UC study). In the PC cohort, we planned to evaluate 1) the inter-group difference of frailty among the different stages and treatments (FRAPC study), the effect of frailty on safety and oncological outcomes 2) between the radical prostatectomy and radiation therapy in patients with localized prostate cancer (FRART-PC study), 3) among the patients with metastatic PC (FRAM-PC study), 4) the association of baseline frailty and quality of life (FRAQ-PC study), and 5) the association of baseline frailty and postoperative pain (FRAP study). In the RCC cohort, we planned to evaluate 1) the inter-group difference of frailty among the different stages and treatments, the effect of frailty on safety and oncological outcomes 2) in the patients with radical or partial nephrectomy (FRARN study), 2) between in the mRCC patients with molecular targeted therapy and/or immunotherapy(FRARMT study), and 4) the association of baseline frailty and quality of life (FRAQ-RCC). Also, we planned to estimate the gap between chronological and biological age using frailty (FRAGE-GAP study).

Management information
Registered date	2020 Year 01 Month 05 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=R000044540