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
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
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
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
