UMIN-CTR 臨床試験登録情報の閲覧

UMIN試験ID UMIN000028533
受付番号 R000032653
科学的試験名 フレイル評価が治療関連合併症、予後に与える影響についての観察研究
一般公開日(本登録希望日) 2017/08/06
最終更新日 2022/12/06 09:07:37

※ 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
フレイル評価が治療関連合併症、予後に与える影響についての観察研究


英語
An observational validation study of the impact of Frailty on posttreatment adverse events and poor prognosis in patients with a patient with urological diseases

一般向け試験名略称/Acronym

日本語
フレイル評価が治療関連合併症、予後に与える影響についての観察研究


英語
An observational validation study of the impact of Frailty on posttreatment adverse events and poor prognosis in patients with a patient with urological diseases

科学的試験名/Scientific Title

日本語
フレイル評価が治療関連合併症、予後に与える影響についての観察研究


英語
An observational validation study of the impact of Frailty on posttreatment adverse events and poor prognosis in patients with a patient with urological diseases

科学的試験名略称/Scientific Title:Acronym

日本語
フレイル評価が治療関連合併症、予後に与える影響についての観察研究


英語
An observational validation study of the impact of Frailty on posttreatment adverse events and poor prognosis in patients with a patient with urological diseases

試験実施地域/Region

日本/Japan


対象疾患/Condition

対象疾患名/Condition

日本語
泌尿器科疾患


英語
Urological diseases

疾患区分1/Classification by specialty

腎臓内科学/Nephrology 内分泌外科学/Endocrine surgery
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 evaluate the validity of Frailty for posttreatment adverse events and poor prognosis in patients with patient with urological diseases in multicenter setting


英語
To evaluate the validity of Frailty for posttreatment adverse events and poor prognosis in patients with patient with urological diseases in multicenter setting

目的2/Basic objectives2

有効性/Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語


英語

試験の性質1/Trial characteristics_1

検証的/Confirmatory

試験の性質2/Trial characteristics_2

実務的/Pragmatic

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 outcomes: Predicting frailty related post-treatment adverse events using Frailty Discriminant score
Secondary outcomes: Comparison of previously reported frailty assessment tools for diagnostic accuracy for frailty, Overall survival, Cancer-specific survival, Postoperative complication, Chemotherapy related to severe adverse events, Clinical indication for definitive therapies (surgery, chemotherapy and/or radiotherapy), Relationship between frailty and quality of life


英語
Primary outcomes: Predicting frailty related post-treatment adverse events using Frailty Discriminant score
Secondary outcomes: Comparison of previously reported frailty assessment tools for diagnostic accuracy for frailty, Overall survival, Cancer-specific survival, Postoperative complication, Chemotherapy related to severe adverse events, Clinical indication for definitive therapies (surgery, chemotherapy and/or radiotherapy), Relationship between frailty and quality of life

副次アウトカム評価項目/Key secondary outcomes

日本語
This study is a part of our prospective observational study (UMIN000025057). We planned the inter-group difference of frailty among the patients with prostate cancer (PC), renal cell carcinoma (RCC), and urothelial carcinoma (UC) when we successfully developed our CGA tool.


英語
This study is a part of our prospective observational study (UMIN000025057). We planned the inter-group difference of frailty among the patients with prostate cancer (PC), renal cell carcinoma (RCC), and urothelial carcinoma (UC) when we successfully developed our CGA tool.


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

20 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
Patients with urological diseases who undergo frailty assessments. Urological diseases include both malignant and non-malignant diseases.


英語
Patients with urological diseases who undergo frailty assessments. Urological diseases include both malignant and non-malignant diseases.

除外基準/Key exclusion criteria

日本語
Patients with urological diseases who could not undergo frailty assessments.


英語
Patients with urological diseases who could not undergo frailty assessments.

目標参加者数/Target sample size

600


責任研究者/Research contact person

責任研究者/Name of lead principal investigator

日本語
真吾
ミドルネーム
畠山


英語
SHINGO
ミドルネーム
Hataeyama

所属組織/Organization

日本語
Hirosaki University


英語
Hirosaki University

所属部署/Division name

日本語
Urology


英語
Urology

郵便番号/Zip code

036-8562

住所/Address

日本語
弘前市在府町5


英語
5 zaifu

電話/TEL

0172395091

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
真吾
ミドルネーム
畠山


英語
SHINGO
ミドルネーム
Hatakeyama

組織名/Organization

日本語
Hirosaki University Graduate School of Medicine


英語
Hirosaki University Graduate School of Medicine

部署名/Division name

日本語
Urology


英語
Urology

郵便番号/Zip code

0368562

住所/Address

日本語
弘前市在府町5


英語
5 zaifu

電話/TEL

0172395091

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 University Graduate School of Medicine

機関名/Institute
(機関選択不可の場合)

日本語
Hirosaki University Graduate School of Medicine


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 University Graduate School of Medicine

機関名/Organization
(機関選択不可の場合)

日本語
Hirosaki University Graduate School of Medicine


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
Japan


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
Hirosaki University Graduate School of Medicine


英語
Hirosaki University School of Medicine

住所/Address

日本語
5 Zaifu-chou


英語
5 Zaifu-chou

電話/Tel

+81172395091

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

2017 08 06


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 FDS is a reliable and valid tool for assessing frailty and prognosis in patients with urological cancers.


英語
The 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.


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.

有害事象/Adverse events

日本語


英語

評価項目/Outcome measures

日本語
The primary outcome was the non-inferiority (margin 5%) of FDS in discriminating patients with urological cancers from controls (Ctrl). 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. FDS was significantly higher in patients with urological cancers than that in the Ctrl.


英語
The primary outcome was the non-inferiority (margin 5%) of FDS in discriminating patients with urological cancers from controls (Ctrl). 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. FDS was significantly higher in patients with urological cancers than that in the Ctrl.

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 07 01

倫理委員会による承認日/Date of IRB

2016 01 06

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

2017 07 02

フォロー終了(予定)日/Last follow-up date

2022 07 02

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
This study is an observational prospective validation study of the impact of Frailty Discriminant score on post-treatment adverse events and poor prognosis in patients with patient with urological diseases in multicenter setting. Patients in this study undergo frailty assessment including G8, gait speed, handgrip strength, fatigue and depression questionnaire, and basic blood biochemical test. Frailty Discriminant score were calculated, and outcomes are prospectively evaluated. Study interval is estimated for 5 years.


英語
This study is an observational prospective validation study of the impact of Frailty Discriminant score on post-treatment adverse events and poor prognosis in patients with patient with urological diseases in multicenter setting. Patients in this study undergo frailty assessment including G8, gait speed, handgrip strength, fatigue and depression questionnaire, and basic blood biochemical test. Frailty Discriminant score were calculated, and outcomes are prospectively evaluated. Study interval is estimated for 5 years.


管理情報/Management information

登録日時/Registered date

2017 08 04

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=R000032653


英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032653


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