NCT05643690暂停不适用
Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay in Subjects Suspected of Having Bladder Cancer
AnchorDx Medical Co. Ltd. US2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2022年11月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Sensitivity and Specificity of UriFind assay in detecting early stage Bladder Cancer
研究概览
简要总结
The AnchorDx UriFind™ Bladder Cancer Assay is designed to detect 2 DNA methylation biomarkers in urine specimens from patients 22 years or older suspected of having bladder cancer. Results from the assay are intended for use, in conjunction with current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Validation Group:
- •55 years or older, gender is not limited
- •Suspected of bladder cancer and are scheduled for bladder biopsy or trans-uretheral resection of bladder tumor (TUBRT)
- •Can receive standard of care, including urine cytology, cystoscopy, or surgery for bladder cancer diagnosis
- •Can provide at least of 75 ml of urine (prior to cystoscopy or surgery)
排除标准
- •History of urinary cancer
- •Neoadjuvant therapy
结局指标
主要结局
Sensitivity and Specificity of UriFind assay in detecting early stage Bladder Cancer
时间窗: Baseline
To evaluate the performance of the UriFind assay relative to the patient at diagnosis (cystoscopy or surgery followed by histology).
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial CarcinomaUrothelial CarcinomaBladder CancerNCT04314245AnchorDx Medical Co., Ltd.1,170
招募中
不适用
Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for Upper Tract Urothelial Carcinoma DetectionUpper Tract Urothelial CarcinomaNCT04948528AnchorDx Medical Co., Ltd.490
招募中
不适用
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical CancerEndometrial CancerAtypical Endometrial HyperplasiaCervical DysplasiaAdnexal MassOvarian CancerCervical CancerNCT05051722Mayo Clinic3,110
进行中（未招募）
不适用
Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary NodulesPulmonary NodulesNCT03651986AnchorDx Medical Co., Ltd.10,560
已完成
不适用
Urine-DNA Biomarkers in Detecting Bladder CancerBiomarkerDiagnosisUrineBladder CancerNCT03066310Xiangya Hospital of Central South University125