UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036497 |
|---|---|
| Receipt number | R000041586 |
| Scientific Title | Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers |
| Date of disclosure of the study information | 2019/04/14 |
| Last modified on | 2022/12/06 08:56:38 |
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Basic information
Public title
Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers
Acronym
Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers
Scientific Title
Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers
Scientific Title:Acronym
Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers
Region
| Japan |
Condition
Condition
Urological cancers (Prostate cancer: PC, bladder cancer: BC, upper tract urothelial carcinoma: UTUC, renal cell carcinoma: RCC)
Controls (Ctrl)
Subjects who participated in the general health survey in the IWAKI health promotion project between 2013 and 2018.
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate the efficacy of f frailty discriminant score (FDS) in patients with urological cancers
Basic objectives2
Others
Basic objectives -Others
Non-inferiority study
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary endpoint: Discrimination of Ctrl with cancer patients using FDS.
Validation of FDS on cancer status between the patients with PC vs. Ctrl, and between the patients with non-PC (BC, UTUC, RCC,) vs. Ctrl.
Sample size calculation for primary endpoints
(http://www.biosoft.hacettepe.edu.tr/easyROC/ ver.1.3.1)
The sample size for non-PC
non-inferiority margin <5% AUC for standard test : 0.967
Sample size calculation for testing noninferiority of a new test to a standard test
-----------------------------------------
Input:
-----------------------------------------
Type I error : 0.025
Power : 0.9
AUC for standard test : 0.967
Allocation ratio : 2
-----------------------------------------
Output:
-----------------------------------------
Case : 139
Control : 287
Total : 417
-----------------------------------------
The sample size for PC
non-inferiority margin <5% in AUC: AUC for standard test : 0.974
-----------------------------------------
Input:
-----------------------------------------
Type I error : 0.025
Power : 0.9
AUC for standard test : 0.974
Allocation ratio : 2
-----------------------------------------
Output:
-----------------------------------------
Case : 102
Control : 204
Total : 306
-----------------------------------------
Key secondary outcomes
Secondary endpoints: Prognostic value
Validation of FDS on prognosis prediction in urological cancer patients between the FDS-high vs. -low. FDS-high and -low were defined >2.3 in non-PC and >3.3 in PC, respectively.
Sample size calculation for secondary endpoints
Overall survival (OS) between the FDS-high and -low.
FDS-high: FDS>2.3 in non-PC patients and >3.3 in PC patients
FDS-low: FDS =<2.3 in non-PC patients and =<3.3 in PC patients
Our sample size calculations were based on the primary outcome of OS. Our previous study suggested the 2-year OS in patients with FDS-high and -low were 73% and 96%, respectively. Using 90% power and 2.5% two-sided alpha, the sample size to illustrate the superiority of FDS-high and -low was 68 participants per arm (an allocation ratio 1:1, total n = 136) will be required. Accounting for 15% withdrawal/loss to follow-up, 156 (78 vs. 78) participants will need to be recruited.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Key inclusion criteria: 1) patients with PC, BC, UTUC, or RCC who can evaluate the frailty using FDS. 2) Agree with the frailty evaluation.
Key exclusion criteria
Key exclusion criteria: 1) patients with cancer except for PC, BC, UTUC, or RCC. 2) patients with severe general condition who could not evaluate the frailty using FDS.
Controls (Ctrl)
Target sample size
926
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki Univ.
Division name
Urology
Zip code
036-8562
Address
5 Zaifu-chou
TEL
+81172395091
shingorilla2@gmail.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki Univ
Division name
Urology
Zip code
036-8562
Address
5 Zaifu-chou
TEL
+81172395091
Homepage URL
shingorilla2@gmail.com
Sponsor or person
Institute
Hirosaki Univ. School of Med.
Institute
Department
Personal name
Funding Source
Organization
Hirosaki Univ. School of Med
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Dept. of Urology, Hirosaki University Graduate School of Medicine
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki Univ. School of Med.
Address
5 Zaifu-chou
Tel
0172-33-5111
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 | 04 | Month | 14 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/31520152/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31520152/
Number of participants that the trial has enrolled
559
Results
The frailty discriminant score (FDS) is a reliable and valid tool for assessing frailty and prognosis in patients with urological cancers.
Results date posted
| 2022 | Year | 12 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We prospectively validate the efficacy of the frailty discriminant score (FDS) in individuals with urological cancers, as there has been growing importance in evaluating frailty in clinical practice.
Participant flow
A prospective, multicenter study was conducted from February 2017 to April 2019. We enrolled 258 patients with urological cancers and 301 community-dwelling participants who were assessed for frailty. Frailty was assessed using FDS that includes ten items, such as physical, mental, and blood biochemical tests. The primary outcome was the non-inferiority (margin 5%) of FDS in discriminating patients with urological cancers from controls (Ctrl).
Adverse events
none
Outcome measures
The sensitivity, specificity, and area under the receiver operating characteristic (AUROC) curve for each predictive test were calculated. The secondary endpoints included the prediction of overall survival between patients with urological cancer who have high and low FDS.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Statistical analyses of clinical data were performed using SPSS ver. 24.0 (IBM, Inc., Armonk, NY, USA), BellCurve for Excel (Social Survey Research Information Co., Ltd., Tokyo, Japan), GraphPad Prism 5.03 (GraphPad Software, San Diego, CA, USA), and R (R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/).
Management information
Registered date
| 2019 | Year | 04 | Month | 13 | 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=R000041586
