臨床試験情報
| 臨床試験ID | : | UMIN000036497 |
| 情報提供元 | : | 大学病院医療情報ネットワーク研究センター |
| 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 |
| 試験の概要 | : | To validate the efficacy of f frailty discriminant score (FDS) in patients with urological cancers |
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基本情報 患者さん一人一人の状況に応じた判断が必要ですので、詳しくは診療を担当している医師にご相談ください |
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| 対象疾患名 | 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. |
| 試験のホームページURL | |
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実施施設＆進捗状況 | |
| 試験実施施設 | |
| 試験のフェーズ | 該当せず |
| 試験進捗状況 | 試験終了 |
| 公開日・最終情報更新日 | 2022/12/06 |
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試験に参加できる条件 | |
| 年齢・性別 | 問わない 男女両方 |
| 選択基準 | 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: 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) |
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問い合わせ先 | |
| 実施責任組織 | |
| 問い合わせ先組織名 | 弘前大学附属病院 |
| 部署名・担当者名 | 泌尿器科 |
| 電話・Email | +81172395091 shingorilla2@gmail.com |
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評価＆介入 | |
| 試験の種類 | 該当無し |
| 介入の目的 | 該当無し |
| 介入の詳細 | |
| 主要な評価項目・方法 | 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 ----------------------------------------- |
| 副次的な評価項目・方法 | 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. |
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