UMIN-CTR 臨床試験登録情報の閲覧

UMIN試験ID UMIN000039055
受付番号 R000044540
科学的試験名 フレイルが根治的膀胱全摘徐術の尿路変向選択に与える影響(FRAUD試験)
一般公開日(本登録希望日) 2020/01/08
最終更新日 2022/12/06 08:52:56

※ 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
フレイルが根治的膀胱全摘徐術の尿路変向選択に与える影響(FRAUD試験)


英語
An observational study of the effect of frailty on the selection of a type of urinary diversion in patients with muscle-invasive bladder cancer: FRAUD study

一般向け試験名略称/Acronym

日本語
フレイルが根治的膀胱全摘徐術の尿路変向選択に与える影響(FRAUD試験)


英語
An observational study of the effect of frailty on the selection of a type of urinary diversion in patients with muscle-invasive bladder cancer: FRAUD study

科学的試験名/Scientific Title

日本語
フレイルが根治的膀胱全摘徐術の尿路変向選択に与える影響(FRAUD試験)


英語
An observational study of the effect of frailty on the selection of a type of urinary diversion in patients with muscle-invasive bladder cancer: FRAUD study

科学的試験名略称/Scientific Title:Acronym

日本語
フレイルが根治的膀胱全摘徐術の尿路変向選択に与える影響(FRAUD試験)


英語
An observational study of the effect of frailty on the selection of a type of urinary diversion in patients with muscle-invasive bladder cancer: FRAUD study

試験実施地域/Region

日本/Japan


対象疾患/Condition

対象疾患名/Condition

日本語
膀胱癌


英語
Urinary bladder cancer

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 investigate the association of the frailty with urinary diversion after radical cystectomy (RC) in patients with muscle-invasive bladder cancer (MIBC).


英語
To investigate the association of the frailty with urinary diversion after radical cystectomy (RC) in patients with muscle-invasive bladder cancer (MIBC).

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


試験の性質2/Trial characteristics_2


試験のフェーズ/Developmental phase



評価/Assessment

主要アウトカム評価項目/Primary outcomes

日本語
The primary purpose was the effect of frailty on urinary diversion selection after radical cystectomy (RC) in patients with muscle-invasive bladder cancer (MIBC).


英語
The primary purpose was the effect of frailty on urinary diversion selection after radical cystectomy (RC) in patients with muscle-invasive bladder cancer (MIBC).

副次アウトカム評価項目/Key secondary outcomes

日本語
Secondary purposes included the association of frailty on complications and the effect of frailty on overall survival.


英語
Secondary purposes included the association of frailty on complications and the effect of frailty on overall survival.


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 未満/>

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語
Localized muscle-invasive bladder cancer patients who underwent radical cystectomy and urinary diversion


英語
Localized muscle-invasive bladder cancer patients who underwent radical cystectomy and urinary diversion

除外基準/Key exclusion criteria

日本語
1) Localized muscle-invasive bladder cancer patients who do not undergo radical cystectomy and urinary diversion, and 2) who do not undergo frailty assessments.


英語
1) Localized muscle-invasive bladder cancer patients who do not undergo radical cystectomy and urinary diversion, and 2) who do not undergo frailty assessments.

目標参加者数/Target sample size

100


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
Hatakeyama

所属組織/Organization

日本語
弘前大学医学部


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

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
青森県弘前市在府町5


英語
5 Zaifu-chou, Hirosaki

電話/TEL

0172395091

Email/Email

shingoh@hirosaki-u.ac.jp


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
畠山
ミドルネーム
真吾


英語
Shingo
ミドルネーム Hatakeyama
Hatakeyama

組織名/Organization

日本語
Dept. of Urology, Hirosaki University Graduate School of Medicine


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

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
青森県弘前市在府町5


英語
5 Zaifu-chou, Hirosaki

電話/TEL

0172395091

試験のホームページURL/Homepage URL


Email/Email

shingoh@hirosaki-u.ac.jp


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
Dept. of Urology, Hirosaki University Graduate School of Medicine

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
Dept. of Urology, Hirosaki University Graduate School of Medicine

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/Other

研究費拠出国/Nationality of Funding Organization

日本語
日本


英語
N/A = Not Applicable


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
Dept. of Urology, Hirosaki University Graduate School of Medicine


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

住所/Address

日本語
青森県弘前市在府町5


英語
Hirosaki

電話/Tel

0172395091

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

2020 01 08


関連情報/Related information

プロトコル掲載URL/URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/32452113/

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/32452113/

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

88

主な結果/Results

日本語
Frailty is significantly associated with the type of urinary diversion, and it should be considered for the selection of urinary diversion in muscle-invasive bladder cancer patients undergoing radical cystectomy.


英語
Frailty is significantly associated with the type of urinary diversion, and it should be considered for the selection of urinary diversion in muscle-invasive bladder cancer patients undergoing radical cystectomy.

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
To investigate the effect of frailty on the type of urinary diversion after radical cystectomy in patients with muscle-invasive bladder cancer.


英語
To investigate the effect of frailty on the type of urinary diversion after radical cystectomy in patients with muscle-invasive bladder cancer.

参加者の流れ/Participant flow

日本語
Between January 2014 and January 2020, we prospectively evaluated frailty in 88 patients with localized muscle-invasive bladder cancer, who had received radical cystectomy and urinary diversion. The selection of the type of urinary diversion was determined by the operating surgeon based on performance status, comorbidities, tumor status and the patient's preference. The frailty evaluation included the Fried phenotype criteria, the modified frailty index and the frailty discriminant score.


英語
Between January 2014 and January 2020, we prospectively evaluated frailty in 88 patients with localized muscle-invasive bladder cancer, who had received radical cystectomy and urinary diversion. The selection of the type of urinary diversion was determined by the operating surgeon based on performance status, comorbidities, tumor status and the patient's preference. The frailty evaluation included the Fried phenotype criteria, the modified frailty index and the frailty discriminant score.

有害事象/Adverse events

日本語
none


英語
none

評価項目/Outcome measures

日本語
We investigated the association between frailty and type of urinary diversion, the effect of frailty on postoperative complications and the effect of frailty on overall survival.


英語
We investigated the association between frailty and type of urinary diversion, the effect of frailty on postoperative complications and the effect of frailty on overall survival.

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 06

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 01 06

フォロー終了(予定)日/Last follow-up date

2022 12 05

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 a retrospective analysis of our prospective observational study (UMIN000025057). We planned to assess the intra-group difference of frailty among the patients with prostate cancer (PC), renal cell carcinoma (RCC), and urothelial carcinoma (UC) after the development of the CGA tool.
In the UC cohort, we planned to evaluate 1) the intra-group difference of frailty among the different stages and treatments, the effect of frailty on safety and oncological outcomes 2) between the radical cystectomy and trimodal therapy in patients with MIBC (FRART-UC study), 3) between the neobladder and non-neobladder in patients with MIBC (FRAUD study), 4) in patients with upper tract urothelial carcinoma (FRAUT study), 5) metastatic urothelial carcinoma who underwent systemic chemotherapy and/or immunotherapy (FRAM-UC study), and 6) the association of baseline frailty and quality of life (FRAQ-UC study).
In the PC cohort, we planned to evaluate 1) the inter-group difference of frailty among the different stages and treatments (FRAPC study), the effect of frailty on safety and oncological outcomes 2) between the radical prostatectomy and radiation therapy in patients with localized prostate cancer (FRART-PC study), 3) among the patients with metastatic PC (FRAM-PC study), 4) the association of baseline frailty and quality of life (FRAQ-PC study), and 5) the association of baseline frailty and postoperative pain (FRAP study).
In the RCC cohort, we planned to evaluate 1) the inter-group difference of frailty among the different stages and treatments, the effect of frailty on safety and oncological outcomes 2) in the patients with radical or partial nephrectomy (FRARN study), 2) between in the mRCC patients with molecular targeted therapy and/or immunotherapy(FRARMT study), and 4) the association of baseline frailty and quality of life (FRAQ-RCC). Also, we planned to estimate the gap between chronological and biological age using frailty (FRAGE-GAP study).


英語
This study is a retrospective analysis of our prospective observational study (UMIN000025057). We planned to assess the intra-group difference of frailty among the patients with prostate cancer (PC), renal cell carcinoma (RCC), and urothelial carcinoma (UC) after the development of the CGA tool.
In the UC cohort, we planned to evaluate 1) the intra-group difference of frailty among the different stages and treatments, the effect of frailty on safety and oncological outcomes 2) between the radical cystectomy and trimodal therapy in patients with MIBC (FRART-UC study), 3) between the neobladder and non-neobladder in patients with MIBC (FRAUD study), 4) in patients with upper tract urothelial carcinoma (FRAUT study), 5) metastatic urothelial carcinoma who underwent systemic chemotherapy and/or immunotherapy (FRAM-UC study), and 6) the association of baseline frailty and quality of life (FRAQ-UC study).
In the PC cohort, we planned to evaluate 1) the inter-group difference of frailty among the different stages and treatments (FRAPC study), the effect of frailty on safety and oncological outcomes 2) between the radical prostatectomy and radiation therapy in patients with localized prostate cancer (FRART-PC study), 3) among the patients with metastatic PC (FRAM-PC study), 4) the association of baseline frailty and quality of life (FRAQ-PC study), and 5) the association of baseline frailty and postoperative pain (FRAP study).
In the RCC cohort, we planned to evaluate 1) the inter-group difference of frailty among the different stages and treatments, the effect of frailty on safety and oncological outcomes 2) in the patients with radical or partial nephrectomy (FRARN study), 2) between in the mRCC patients with molecular targeted therapy and/or immunotherapy(FRARMT study), and 4) the association of baseline frailty and quality of life (FRAQ-RCC). Also, we planned to estimate the gap between chronological and biological age using frailty (FRAGE-GAP study).


管理情報/Management information

登録日時/Registered date

2020 01 05

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=R000044540


英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044540


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