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

Email

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


Email

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

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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name