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利用者名
UMIN ID

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000038559
受付番号 R000043931
科学的試験名 膀胱癌におけるフレイルが治療選択に与える影響 (FRART-BC study)
一般公開日(本登録希望日) 2019/11/13
最終更新日 2022/12/06

※ 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 膀胱癌におけるフレイルが治療選択に与える影響 (FRART-BC study) An observational study of the effect of frailty on treatment modality selection in patients with muscle-invasive bladder cancer: FRART-BC study
一般向け試験名略称/Acronym 膀胱癌におけるフレイルが治療選択に与える影響 (FRART-BC study) An observational study of the effect of frailty on treatment modality selection in patients with muscle-invasive bladder cancer: FRART-BC study
科学的試験名/Scientific Title 膀胱癌におけるフレイルが治療選択に与える影響 (FRART-BC study) An observational study of the effect of frailty on treatment modality selection in patients with muscle-invasive bladder cancer: FRART-BC study
科学的試験名略称/Scientific Title:Acronym 膀胱癌におけるフレイルが治療選択に与える影響 (FRART-BC study) An observational study of the effect of frailty on treatment modality selection in patients with muscle-invasive bladder cancer: FRART-BC study
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 膀胱癌 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 膀胱癌におけるフレイルが治療選択に与える影響を検討する To investigate the association between the frailty and treatment selection in patients with bladder cancer.
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2
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 Primary purpose was the comparison of frailty between the patients who underwent radical cystectomy (RC group) and trimodal therapy for bladder preservation (TMT group). Primary purpose was the comparison of frailty between the patients who underwent radical cystectomy (RC group) and trimodal therapy for bladder preservation (TMT group).
副次アウトカム評価項目/Key secondary outcomes Secondary purposes included the prevalence of frailty and the effect of frailty on treatment selection between the RC and TMT groups.
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.
Secondary purposes included the prevalence of frailty and the effect of frailty on treatment selection between the RC and TMT groups.
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.

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

介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


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 Patients with muscle invasive bladder cancer
Patients with frailty evaluation before surgery or trimodal therapy for bladder preservation
Patients with muscle invasive bladder cancer
Patients with frailty evaluation before surgery or trimodal therapy for bladder preservation
除外基準/Key exclusion criteria Patients with bladder cancer who were not eligible for radical therapy such as radical cystectomy or trimodal therapy for bladder preservation Patients with bladder cancer who were not eligible for radical therapy such as radical cystectomy or trimodal therapy for bladder preservation
目標参加者数/Target sample size 200

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
真吾
ミドルネーム
畠山
Shingo
ミドルネーム
Hatakeyama
所属組織/Organization Hirosaki University School of Medicine Hirosaki University School of Medicine
所属部署/Division name Urology Urology
郵便番号/Zip code 036-8562
住所/Address 5 Zaifu-chou, Hirosaki 5 Zaifu-chou, Hirosaki
電話/TEL +81172395091
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
真吾
ミドルネーム
畠山
Shingo
ミドルネーム Yamamoto
Hatakeyama
組織名/Organization Hirosaki University School of Medicine Hirosaki University School of Medicine
部署名/Division name Urology Urology
郵便番号/Zip code 036-8562
住所/Address 5 Zaifu-chou, Hirosaki 5 Zaifu-chou, Hirosaki
電話/TEL +81172395091
試験のホームページURL/Homepage URL
Email/Email shingoh@hirosaki-u.ac.jp

実施責任組織/Sponsor
機関名/Institute 弘前大学 Hirosaki University School of Medicine
機関名/Institute
(機関選択不可の場合)

部署名/Department Urology

研究費提供組織/Funding Source
機関名/Organization 弘前大学 Hirosaki University School of Medicine
機関名/Organization
(機関選択不可の場合)

組織名/Division Urology
組織の区分/Category of Funding Organization 日本の官庁/Japanese Governmental office
研究費拠出国/Nationality of Funding Organization 日本 Japan

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

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


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization Hirosaki University School of Medicine Hirosaki University School of Medicine
住所/Address 5 Zaifu-chou 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

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

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 11 13

関連情報/Related information
プロトコル掲載URL/URL releasing protocol https://pubmed.ncbi.nlm.nih.gov/33850749/
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/33850749/
組み入れ参加者数/Number of participants that the trial has enrolled 169
主な結果/Results Frailty was significantly different between the RC and TMT in patients with MIBC and might be one of the key factors for treatment selection. Frailty was significantly different between the RC and TMT in patients with MIBC and might be one of the key factors for treatment selection.
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

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

参加者の流れ/Participant flow Frailty was evaluated in 169 patients with MIBC from January 2014 to September 2020 using the Fried phenotype, modified frailty index, and frailty discriminant score. Frailty was evaluated in 169 patients with MIBC from January 2014 to September 2020 using the Fried phenotype, modified frailty index, and frailty discriminant score.
有害事象/Adverse events none none
評価項目/Outcome measures The primary purpose was comparing the frailty between the patients who underwent radical cystectomy (RC) with those who had trimodal therapy (TMT) for bladder preservation. Secondary purposes were comparing the frailty between the groups and the effect of TMT on overall survival adjusting the frailty by multivariate Cox proportional hazards analysis using inverse probability of treatment The primary purpose was comparing the frailty between the patients who underwent radical cystectomy (RC) with those who had trimodal therapy (TMT) for bladder preservation. Secondary purposes were comparing the frailty between the groups and the effect of TMT on overall survival adjusting the frailty by multivariate Cox proportional hazards analysis using inverse probability of treatment
個別症例データ共有計画/Plan to share IPD

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


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 01
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 We evaluate frailty in patients with MIBC using modified Frailty index, Fried phenotype, and frailty discriminant score. Primary purpose was comparison of frailty between the patients who underwent radical cystectomy (RC group) and trimodal therapy for bladder preservation (TMT group). Secondary purposes were the prevalence of frailty between the groups and the effect of frailty on treatment selection. Exploratory purpose included overall survival (OS) comparison between the groups using the inverse probability of treatment weighting Cox regression model.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) when we successfully developed our 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-BC 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). We evaluate frailty in patients with MIBC using modified Frailty index, Fried phenotype, and frailty discriminant score. Primary purpose was comparison of frailty between the patients who underwent radical cystectomy (RC group) and trimodal therapy for bladder preservation (TMT group). Secondary purposes were the prevalence of frailty between the groups and the effect of frailty on treatment selection. Exploratory purpose included overall survival (OS) comparison between the groups using the inverse probability of treatment weighting Cox regression model.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) when we successfully developed our 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-BC 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).

管理情報/Management information
登録日時/Registered date
2019 11 12
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
URL(日本語) https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043931
URL(英語) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043931

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


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