Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers

Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers - Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036497

Enrollment

926

Registered

2019-04-14

Start date

2017-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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 -----------------------------------------	—

Measure

Time frame

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 -----------------------------------------

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactShingo Hatakeyama

Hirosaki Univ Urology

shingorilla2@gmail.com+81172395091

Outcome results