UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038559
Receipt number 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 2022/12/06 09:11:10

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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

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 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 or person

Institute

Hirosaki University School of Medicine

Institute

Department

Personal name



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

https://pubmed.ncbi.nlm.nih.gov/33850749/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/33850749/

Number of participants that the trial has enrolled

169

Results

Frailty was significantly different between the RC and TMT in patients with MIBC and might be one of the key factors for treatment selection.

Results date posted

2022 Year 12 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow

Frailty was evaluated in 169 patients with MIBC from January 2014 to September 2020 using the Fried phenotype, modified frailty index, and frailty discriminant score.

Adverse events

none

Outcome measures

The primary purpose was comparing the frailty between the patients who underwent radical cystectomy (RC) with those who had trimodal therapy (TMT) for bladder preservation. Secondary purposes were comparing the frailty between the groups and the effect of TMT on overall survival adjusting the frailty by multivariate Cox proportional hazards analysis using inverse probability of treatment

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 01 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

2022 Year 12 Month 06 Day



Link to view the page

Value
https://center6.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