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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038559
Receipt No. R000043931
Scientific Title An observational study of the effect of frailty on treatment modality selection in patients with muscle-invasive bladder cancer: FRART-BC study
Date of disclosure of the study information 2019/11/13
Last modified on 2020/04/16

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Basic information
Public title An observational study of the effect of frailty on treatment modality selection in patients with muscle-invasive bladder cancer: FRART-BC study
Acronym An observational study of the effect of frailty on treatment modality selection in patients with muscle-invasive bladder cancer: FRART-BC study
Scientific Title An observational study of the effect of frailty on treatment modality selection in patients with muscle-invasive bladder cancer: FRART-BC study
Scientific Title:Acronym An observational study of the effect of frailty on treatment modality selection in patients with muscle-invasive bladder cancer: FRART-BC 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 between the frailty and treatment selection in patients with bladder cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Primary purpose was the comparison of frailty between the patients who underwent radical cystectomy (RC group) and trimodal therapy for bladder preservation (TMT group).
Key secondary outcomes Secondary purposes included the prevalence of frailty and the effect of frailty on treatment selection between the RC and TMT groups.
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.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Radical cystectomy or trimodal therapy (TMT) consisting of maximal transurethral resection of the bladder tumor (TURBT) followed by concurrent chemotherapy and radiation therapy.
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 muscle invasive bladder cancer
Patients with frailty evaluation before surgery or trimodal therapy for bladder preservation
Key exclusion criteria Patients with bladder cancer who were not eligible for radical therapy such as radical cystectomy or trimodal therapy for bladder preservation
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Shingo
Middle name
Last name Hatakeyama
Organization Hirosaki University School of Medicine
Division name Urology
Zip code 036-8562
Address 5 Zaifu-chou, Hirosaki
TEL +81172395091
Email shingoh@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name Shingo
Middle name Yamamoto
Last name Hatakeyama
Organization Hirosaki University School of Medicine
Division name Urology
Zip code 036-8562
Address 5 Zaifu-chou, Hirosaki
TEL +81172395091
Homepage URL
Email shingoh@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University School of Medicine
Institute
Department

Funding Source
Organization Hirosaki University School of Medicine
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2019 Year 11 Month 13 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 We evaluate frailty in patients with MIBC using modified Frailty index, Fried phenotype, and frailty discriminant score. Primary purpose was comparison of frailty between the patients who underwent radical cystectomy (RC group) and trimodal therapy for bladder preservation (TMT group). Secondary purposes were the prevalence of frailty between the groups and the effect of frailty on treatment selection. Exploratory purpose included overall survival (OS) comparison between the groups using the inverse probability of treatment weighting Cox regression model.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) when we successfully developed our 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-BC 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).

Management information
Registered date
2019 Year 11 Month 12 Day
Last modified on
2020 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043931

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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