即将开始 NCT07095751

人工智能辅助 Uro-Cam 导管评估系统用于诊断膀胱癌

膀胱癌/尿路上皮癌不适用III 期

这是一项单臂研究,探讨将于威尔斯亲王医院进行的人工智能辅助 Uro-Cam 导管评估的安全性、可行性及诊断表现。所有因血尿检查转介至泌尿科门诊的患者,以及需要接受膀胱镜随访的膀胱癌患者,均将接受研究资格筛查。

适应症:Bladder Cancer

入组条件

纳入标准

  • Age 18 years or above
  • Fulfil any one of the following three criteria: (1) Macroscopic haematuria or persistent microscopic haematuria (microscopic haematuria in at least two urine tests), (2) Abnormal urine cytology results (Atypical cells in at least two urine cytology tests, OR Suspicious cells or malignant cells in at least one urine cytology test), (3)History of non-muscle-invasive bladder cancer with complete transurethral resection of bladder tumour performed

排除标准

  • Presence of clinically significant cardiovascular disease (History of acute myocardial infarction, presence of uncontrolled angina within 3 months before screening, New York Heart Association Class III or IV congestive heart failure, presence of ventricular arrhythmias, or presence of second-degree or third-degree heart block)
  • Any evidence of active urinary tract infection
  • Presence of GOLD Stage III or IV chronic obstructive pulmonary disease
  • ECOG performance status ≥ 2 (Ambulatory and capable of all self-care but unable to carry our any work activities)
  • History of bleeding disorder or use of anti-coagulants
  • Presence of other active malignancy
  • Pregnancy

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。