UMIN試験ID | UMIN000036497 |
---|---|
受付番号 | R000041586 |
科学的試験名 | 泌尿器癌患者におけるフレイル(虚弱性)評価のバリデーション研究 |
一般公開日(本登録希望日) | 2019/04/14 |
最終更新日 | 2022/12/06 08:56:38 |
日本語
泌尿器癌患者におけるフレイル(虚弱性)評価のバリデーション研究
英語
Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers
日本語
泌尿器癌患者におけるフレイル(虚弱性)評価のバリデーション研究
英語
Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers
日本語
泌尿器癌患者におけるフレイル(虚弱性)評価のバリデーション研究
英語
Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers
日本語
泌尿器癌患者におけるフレイル(虚弱性)評価のバリデーション研究
英語
Validation study of the efficacy of frailty discriminant score (FDS) in patients with urological cancers
日本/Japan |
日本語
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.
英語
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.
泌尿器科学/Urology |
悪性腫瘍/Malignancy
いいえ/NO
日本語
To validate the efficacy of f frailty discriminant score (FDS) in patients with urological cancers
英語
To validate the efficacy of f frailty discriminant score (FDS) in patients with urological cancers
その他/Others
日本語
Non-inferiority study
英語
Non-inferiority study
検証的/Confirmatory
説明的/Explanatory
該当せず/Not applicable
日本語
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
-----------------------------------------
英語
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
-----------------------------------------
日本語
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 α, 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.
英語
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.
観察/Observational
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
18 | 歳/years-old | 以上/<= |
100 | 歳/years-old | 以下/>= |
男女両方/Male and Female
日本語
Key inclusion criteria: 1) patients with PC, BC, UTUC, or RCC who can evaluate the frailty using FDS. 2) Agree with the frailty evaluation.
英語
Key inclusion criteria: 1) patients with PC, BC, UTUC, or RCC who can evaluate the frailty using FDS. 2) Agree with the frailty evaluation.
日本語
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)
英語
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)
926
日本語
名 | 畠山 |
ミドルネーム | |
姓 | 真吾 |
英語
名 | Shingo |
ミドルネーム | |
姓 | Hatakeyama |
日本語
弘前大学附属病院
英語
Hirosaki Univ.
日本語
泌尿器科
英語
Urology
036-8562
日本語
5 Zaifu-chou
英語
5 Zaifu-chou
+81172395091
shingorilla2@gmail.com
日本語
名 | Shingo |
ミドルネーム | |
姓 | Hatakeyama |
英語
名 | Shingo |
ミドルネーム | |
姓 | Hatakeyama |
日本語
弘前大学附属病院
英語
Hirosaki Univ
日本語
泌尿器科
英語
Urology
036-8562
日本語
5 Zaifu-chou
英語
5 Zaifu-chou
+81172395091
shingorilla2@gmail.com
日本語
弘前大学
英語
Hirosaki Univ. School of Med.
日本語
日本語
日本語
英語
日本語
弘前大学
英語
Hirosaki Univ. School of Med
日本語
日本語
その他の国の官庁/Government offices of other countries
日本語
日本
英語
Dept. of Urology, Hirosaki University Graduate School of Medicine
日本語
英語
日本語
英語
日本語
弘前大学医学部
英語
Hirosaki Univ. School of Med.
日本語
〒036-8562 青森県弘前市在府町5
英語
5 Zaifu-chou
0172-33-5111
rinri@hirosaki-u.ac.jp
いいえ/NO
日本語
英語
日本語
英語
2019 | 年 | 04 | 月 | 14 | 日 |
https://pubmed.ncbi.nlm.nih.gov/31520152/
最終結果が公表されている/Published
https://pubmed.ncbi.nlm.nih.gov/31520152/
559
日本語
The frailty discriminant score (FDS) is a reliable and valid tool for assessing frailty and prognosis in patients with urological cancers.
英語
The frailty discriminant score (FDS) is a reliable and valid tool for assessing frailty and prognosis in patients with urological cancers.
2022 | 年 | 12 | 月 | 06 | 日 |
日本語
英語
日本語
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.
英語
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.
日本語
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).
英語
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).
日本語
none
英語
none
日本語
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.
英語
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.
日本語
英語
日本語
英語
試験終了/Completed
2017 | 年 | 01 | 月 | 31 | 日 |
2017 | 年 | 01 | 月 | 06 | 日 |
2017 | 年 | 07 | 月 | 01 | 日 |
2022 | 年 | 07 | 月 | 31 | 日 |
日本語
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/).
英語
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/).
2019 | 年 | 04 | 月 | 13 | 日 |
2022 | 年 | 12 | 月 | 06 | 日 |
日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041586
英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041586
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