UMIN-CTR 臨床試験登録情報の閲覧

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

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information

一般向け試験名/Public title

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

一般向け試験名略称/Acronym

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

科学的試験名/Scientific Title

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

科学的試験名略称/Scientific Title:Acronym

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

試験実施地域/Region

日本/Japan


対象疾患/Condition

対象疾患名/Condition

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.

疾患区分1/Classification by specialty

泌尿器科学/Urology

疾患区分2/Classification by malignancy

悪性腫瘍/Malignancy

ゲノム情報の取扱い/Genomic information

いいえ/NO


目的/Objectives

目的1/Narrative objectives1

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

目的2/Basic objectives2

その他/Others

目的2 -その他詳細/Basic objectives -Others

日本語
Non-inferiority study


英語
Non-inferiority study

試験の性質1/Trial characteristics_1

検証的/Confirmatory

試験の性質2/Trial characteristics_2

説明的/Explanatory

試験のフェーズ/Developmental phase

該当せず/Not applicable


評価/Assessment

主要アウトカム評価項目/Primary outcomes

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

副次アウトカム評価項目/Key secondary outcomes

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.


基本事項/Base

試験の種類/Study type

観察/Observational


試験デザイン/Study design

基本デザイン/Basic design


ランダム化/Randomization


ランダム化の単位/Randomization unit


ブラインド化/Blinding


コントロール/Control


層別化/Stratification


動的割付/Dynamic allocation


試験実施施設の考慮/Institution consideration


ブロック化/Blocking


割付コードを知る方法/Concealment



介入/Intervention

群数/No. of arms


介入の目的/Purpose of intervention


介入の種類/Type of intervention


介入1/Interventions/Control_1

日本語


英語

介入2/Interventions/Control_2

日本語


英語

介入3/Interventions/Control_3

日本語


英語

介入4/Interventions/Control_4

日本語


英語

介入5/Interventions/Control_5

日本語


英語

介入6/Interventions/Control_6

日本語


英語

介入7/Interventions/Control_7

日本語


英語

介入8/Interventions/Control_8

日本語


英語

介入9/Interventions/Control_9

日本語


英語

介入10/Interventions/Control_10

日本語


英語


適格性/Eligibility

年齢(下限)/Age-lower limit

18 歳/years-old 以上/<=

年齢(上限)/Age-upper limit

100 歳/years-old 以下/>=

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

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.

除外基準/Key exclusion criteria

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)

目標参加者数/Target sample size

926


責任研究者/Research contact person

責任研究者/Name of lead principal investigator

日本語
畠山
ミドルネーム
真吾


英語
Shingo
ミドルネーム
Hatakeyama

所属組織/Organization

日本語
弘前大学附属病院


英語
Hirosaki Univ.

所属部署/Division name

日本語
泌尿器科


英語
Urology

郵便番号/Zip code

036-8562

住所/Address

日本語
5 Zaifu-chou


英語
5 Zaifu-chou

電話/TEL

+81172395091

Email/Email

shingorilla2@gmail.com


試験問い合わせ窓口/Public contact

試験問い合わせ窓口担当者/Name of contact person

日本語
Shingo
ミドルネーム
Hatakeyama


英語
Shingo
ミドルネーム
Hatakeyama

組織名/Organization

日本語
弘前大学附属病院


英語
Hirosaki Univ

部署名/Division name

日本語
泌尿器科


英語
Urology

郵便番号/Zip code

036-8562

住所/Address

日本語
5 Zaifu-chou


英語
5 Zaifu-chou

電話/TEL

+81172395091

試験のホームページURL/Homepage URL


Email/Email

shingorilla2@gmail.com


実施責任個人または組織/Sponsor or person

機関名/Institute

日本語
弘前大学


英語
Hirosaki Univ. School of Med.

機関名/Institute
(機関選択不可の場合)

日本語


部署名/Department

日本語


個人名/Personal name

日本語


英語


研究費提供組織/Funding Source

機関名/Organization

日本語
弘前大学


英語
Hirosaki Univ. School of Med

機関名/Organization
(機関選択不可の場合)

日本語


組織名/Division

日本語


組織の区分/Category of Funding Organization

その他の国の官庁/Government offices of other countries

研究費拠出国/Nationality of Funding Organization

日本語
日本


英語
Dept. of Urology, Hirosaki University Graduate School of Medicine


その他の関連組織/Other related organizations

共同実施組織/Co-sponsor

日本語


英語

その他の研究費提供組織/Name of secondary funder(s)

日本語


英語


IRB等連絡先(公開)/IRB Contact (For public release)

組織名/Organization

日本語
弘前大学医学部


英語
Hirosaki Univ. School of Med.

住所/Address

日本語
〒036-8562 青森県弘前市在府町5


英語
5 Zaifu-chou

電話/Tel

0172-33-5111

Email/Email

rinri@hirosaki-u.ac.jp


他機関から発行された試験ID/Secondary IDs

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1


ID発行機関1/Org. issuing International ID_1

日本語


英語

試験ID2/Study ID_2


ID発行機関2/Org. issuing International ID_2

日本語


英語

治験届/IND to MHLW



試験実施施設/Institutions

試験実施施設名称/Institutions



その他の管理情報/Other administrative information

一般公開日(本登録希望日)/Date of disclosure of the study information

2019 04 14


関連情報/Related information

プロトコル掲載URL/URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/31520152/

試験結果の公開状況/Publication of results

最終結果が公表されている/Published


結果/Result

結果掲載URL/URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/31520152/

組み入れ参加者数/Number of participants that the trial has enrolled

559

主な結果/Results

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.

主な結果入力日/Results date posted

2022 12 06

結果掲載遅延/Results Delayed


結果遅延理由/Results Delay Reason

日本語


英語

最初の試験結果の出版日/Date of the first journal publication of results


参加者背景/Baseline Characteristics

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.

参加者の流れ/Participant flow

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).

有害事象/Adverse events

日本語
none


英語
none

評価項目/Outcome measures

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.

個別症例データ共有計画/Plan to share IPD

日本語


英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語


英語


試験進捗状況/Progress

試験進捗状況/Recruitment status

試験終了/Completed

プロトコル確定日/Date of protocol fixation

2017 01 31

倫理委員会による承認日/Date of IRB

2017 01 06

登録・組入れ開始(予定)日/Anticipated trial start date

2017 07 01

フォロー終了(予定)日/Last follow-up date

2022 07 31

入力終了(予定)日/Date of closure to data entry


データ固定(予定)日/Date trial data considered complete


解析終了(予定)日/Date analysis concluded



その他/Other

その他関連情報/Other related information

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/).


管理情報/Management information

登録日時/Registered date

2019 04 13

最終更新日/Last modified on

2022 12 06



閲覧ページへのリンク/Link to view the page

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


研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名