Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of positive utDNA for urothelial cancer within one year of follow-up
研究概览
简要总结
Lynch syndrome (LS) is an inherited cancer predisposition syndrome caused by pathogenic germline variants in DNA mismatch repair (MMR) genes. New cancer screening and diagnostic tools are urgently needed to identify LS-related cancers early enough for curative treatment. Urothelial cancers (comprising bladder and upper tract urothelial tumors) are the third most common cancer after colorectal and endometrial cancers in individuals with LS. Up to one in four LS individuals will develop urothelial cancer during their lifetime, with the risk varying based on the defective MMR gene. In this clinical trial, we will employ urine tumor DNA (utDNA) to identify asymptomatic urothelial cancers in Lynch syndrome patients, and to investigate the potential benefits of urine tumor DNA based screening in this high-risk population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to provide informed consent
- •Diagnosis of Lynch syndrome
- •Age 50 - 75 years at study recruitment
排除标准
- •Concurrent urothelial carcinoma
结局指标
主要结局
Sensitivity and specificity of positive utDNA for urothelial cancer within one year of follow-up
时间窗: At 1 years of follow-up
Sensitivity and specificity of positive utDNA for urothelial cancer, using histologically verified cancers detected within 1 year of the utDNA test as ground truth
次要结局
- Size of urothelial tumors(At 2, 5 and 10 years of follow-up)
- Sensitivity and specificity of positive utDNA for urothelial cancer within multiple years of follow-up(At 2, 5, and 10 years of follow-up)
- Overall survival(At 5 and 10 years of follow-up)
- Urothelial cancer specific survival(At 3, 5 and 10 years of follow-up)
- Time to metastatic urothelial cancer(At 5 and 10 years of follow-up)
- Time to diagnosis of urothelial cancer(At 2, 5 and 10 years of follow-up)
- Urothelial cancer grade(At 2, 5 and 10 years of follow-up)
- Specificity of positive utDNA for urothelial cancer at the time of testing(After all patients with positive utDNA have been evaluated with cystoscopy and/or imaging)
- Time to diagnosis of muscle invasive or high grade urothelial cancer(At 2, 5 and 10 years of follow-up)
- TNM pathological stage of urothelial cancers(At 2, 5 and 10 years of follow-up)