UMIN-ICDS 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語
転移性尿路上皮癌におけるフレイルが予後に与える影響(FRA-mUC study)

英語
Effect of frailty on prognosis in patients with metastatic urothelial carcinoma(FRAmUC study)

一般向け試験名略称/Acronym

日本語
転移性尿路上皮癌におけるフレイルが予後に与える影響(FRA-mUC study)

英語
Effect of frailty on prognosis in patients with metastatic urothelial carcinoma(FRA-mUC study)

科学的試験名/Scientific Title

日本語
転移性尿路上皮癌におけるフレイルが予後に与える影響(FRA-mUC study)

英語
An observational study of the effect of frailty on prognosis in patients with metastatic urothelial carcinoma(FRA-mUC study)

科学的試験名略称/Scientific Title:Acronym

日本語
転移性尿路上皮癌におけるフレイルが予後に与える影響(FRAM-UC study)

英語
An observational study of the effect of frailty on prognosis in patients with metastatic urothelial carcinoma(FRA-mUC study)

試験実施地域/Region

日本/Japan

対象疾患名/Condition

日本語
metastatic urothelial carcinoma

英語
metastatic urothelial carcinoma

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1/Narrative objectives1

日本語
To investigate the association between the frailty and prognosis in patients with metastatic urothelial carcinoma

英語
To investigate the association between the frailty and prognosis in patients with metastatic urothelial carcinoma

目的2/Basic objectives2

安全性・有効性/Safety,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

主要アウトカム評価項目/Primary outcomes

日本語
The primary outcome was the effect of frailty on tumor response in patients with metastatic urothelial carcinoma

英語
The primary outcome was the effect of frailty on progression-free survival in patients with metastatic urothelial carcinoma

副次アウトカム評価項目/Key secondary outcomes

日本語
Secondary outcomes included safety, progression-free survival, and overall survival.

英語
Secondary outcomes included safety, progression-free survival, and overall survival.

試験の種類/Study type

観察/Observational

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

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

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/Male

選択基準/Key inclusion criteria

日本語
Patients with metastatic urothelial carcinoma who were 1) treated with standard of care,2) evaluated with frailty

英語
Patients with metastatic urothelial carcinoma who were 1) treated with standard of care,2) evaluated with frailty

除外基準/Key exclusion criteria

日本語
Patients with metastatic urothelial carcinoma who were not treated with standard of care or no frailty evaluation.

英語
Patients with metastatic urothelial carcinoma who were not treated with standard of care or no frailty evaluation.

目標参加者数/Target sample size

200

責任研究者/Name of lead principal investigator

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

所属組織/Organization

日本語
Hirosaki University School of Medicine

英語
Hirosaki University 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
5 Zaifu-chou

英語
Hirosaki

電話/TEL

0172395091

Email/Email

shingorilla2@gmail.com

試験問い合わせ窓口担当者/Name of contact person

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

組織名/Organization

日本語
Hirosaki University School of Medicine

英語
Hirosaki University School of Medicine

部署名/Division name

日本語
Urology

英語
Urology

郵便番号/Zip code

036-8562

住所/Address

日本語
5 Zaifu-chou

英語
Hirosaki

電話/TEL

0172395091

試験のホームページURL/Homepage URL

Email/Email

shingorilla2@gmail.com

機関名/Institute

日本語
弘前大学

英語
Hirosaki University 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

機関名/Organization

日本語
弘前大学

英語
Hirosaki University 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

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

組織名/Organization

日本語
Hirosaki University School of Medicine

英語
Hirosaki University School of Medicine

住所/Address

日本語
5 Zaifu-chou

英語
Hirosaki

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

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

試験実施施設名称/Institutions

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

2020

年

03

月

20

日

プロトコル掲載URL/URL releasing protocol

試験結果の公開状況/Publication of results

未公表/Unpublished

結果掲載URL/URL related to results and publications

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

主な結果/Results

日本語

英語

主な結果入力日/Results date posted

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

英語

参加者の流れ/Participant flow

日本語

英語

有害事象/Adverse events

日本語

英語

評価項目/Outcome measures

日本語

英語

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/Recruitment status

限定募集中/Enrolling by invitation

プロトコル確定日/Date of protocol fixation

2017

年

01

月

06

日

倫理委員会による承認日/Date of IRB

2017

年

01

月

06

日

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

2017

年

01

月

06

日

フォロー終了(予定)日/Last follow-up date

2025

年

03

月

31

日

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

その他関連情報/Other related information

日本語
This study is a part 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 part 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).

登録日時/Registered date

2020

年

03

月

19

日

最終更新日/Last modified on

2023

年

03

月

21

日

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/icdr/ctr_view.cgi?recptno=R000045480

英語
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045480