Vasdev Nikhil, Hampson Alexander, Agarwal Samita, Swamy Rajiv, Chilvers Michael, Hampson Amy, Jahanfard Sholeh, Kim Nam
Hertfordshire and Bedfordshire Urological Cancer Centre Department of Urology Lister Hospital Stevenage UK.
School of Life and Medical Sciences University of Hertfordshire Hatfield UK.
BJUI Compass. 2020 Oct 20;2(1):46-52. doi: 10.1002/bco2.50. eCollection 2021 Jan.
Novel biomarker research is vital for the progression of safe and thorough diagnostic medicine. There is now a need to improve the diagnosis of bladder cancer via a noninvasive urine test while balancing the risks of harm from investigational procedures, such as cystoscopy and radiological tests, against the likelihood of malignancy. We evaluate the diagnostic accuracy and sensitivity of Uro17™ urinary biomarker for the detection of urothelial cancer in hematuria patients in a prospective blinded validation study. Uro17™ is an immunobiomarker which binds to the oncoprotein Keratin 17, which is involved in the replication cycle of malignant cells. This study compared cystoscopic and histological investigations against Uro17™ results in patients being investigated for symptoms of urothelial cancer.
After receiving both local and national ethics/protocol approval, 71 patients were consented and recruited into the study. All patients were scheduled to undergo cystoscopic investigation, and following recruitment, a urine sample was collected. Urine samples were anonymized and processed as per standard cytology protocols and stained using Uro17™ immunobiomarker. The pathologists assessing the results were blinded to the patient and background history, and the results were compared to the biopsy histology.
The full cohort of enrolled patients consisted of 71 participants included. There were 55 males and 16 females, with an average age of 70. Thirteen were current smokers, 42 ex-smokers, and 16 nonsmokers. The malignancies detected included both muscle-invasive (n = 6) and non-muscle-invasive tumors (n = 38), and tumors of all grades and carcinoma in situ. Uro17™ was shown to have an overall sensitivity of 100% and a specificity of 92.6%, with a positive predictive value of 0.957 and negative predictive value of 1. Uro17™ investigation was positive in every case of urothelial malignancy.
Our current data indicates Uro17™ is a highly sensitive noninvasive bladder cancer urine detection test that can improve the diagnosis of Bladder cancer. This can further improve diagnostic capabilities in primary care, reduce the number of referrals to Urology department, and reduce the number of unnecessary invasive procedures for new patients with a suspected urinary bladder cancer.
新型生物标志物研究对于安全、全面的诊断医学发展至关重要。目前需要通过无创尿液检测改善膀胱癌诊断，同时平衡诸如膀胱镜检查和放射学检查等研究性程序带来的伤害风险与恶性肿瘤发生的可能性。我们在一项前瞻性盲法验证研究中评估了Uro17™尿液生物标志物在血尿患者中检测尿路上皮癌的诊断准确性和敏感性。Uro17™是一种免疫生物标志物，可与参与恶性细胞复制周期的癌蛋白角蛋白17结合。本研究将膀胱镜检查和组织学检查结果与接受尿路上皮癌症状检查患者的Uro17™检测结果进行了比较。
在获得当地和国家伦理/方案批准后，71名患者同意并被纳入研究。所有患者均计划接受膀胱镜检查，招募后收集尿液样本。尿液样本匿名处理，并按照标准细胞学方案进行处理，使用Uro17™免疫生物标志物进行染色。评估结果的病理学家对患者和背景病史不知情，结果与活检组织学结果进行比较。
纳入研究的患者全队列包括71名参与者。其中男性55名，女性16名，平均年龄70岁。13名是当前吸烟者，42名是既往吸烟者，16名是非吸烟者。检测到的恶性肿瘤包括肌层浸润性肿瘤（n = 6）和非肌层浸润性肿瘤（n = 38），以及所有分级的肿瘤和原位癌。结果显示Uro17™的总体敏感性为100%，特异性为92.6%，阳性预测值为0.957，阴性预测值为1。在每一例尿路上皮恶性肿瘤病例中，Uro17™检测均为阳性。
我们目前的数据表明，Uro17™是一种高度敏感的无创膀胱癌尿液检测试验，可改善膀胱癌的诊断。这可进一步提高初级医疗保健中的诊断能力，减少转诊至泌尿外科的数量，并减少疑似膀胱癌新患者不必要的侵入性检查数量。
