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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036497
Receipt No. 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 2019/04/14

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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
Institute Hirosaki Univ. School of Med.
Institute
Department

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
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 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
2019 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.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


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