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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039055
Receipt No. R000044540
Scientific Title A prospective 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
Date of disclosure of the study information 2020/01/08
Last modified on 2020/07/02

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Basic information
Public title A prospective 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 A prospective 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 A prospective 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 A prospective 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
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
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a part 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
2020 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044540

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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