NCT05234177招募中不适用
Tempus CRC Surveillance Study: A Longitudinal Circulating Tumor DNA (ctDNA) Biomarker Profiling Study of Patients With Colorectal Cancer (CRC) Using Comprehensive Next-Generation Sequencing (NGS)Assays
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Tempus AI
- 入组人数
- 300
- 试验地点
- 20
- 主要终点
- Recurrence-Free Survival
研究概览
简要总结
The study is an observational multicenter evaluation of participants with colorectal cancer (CRC) who will receive longitudinal plasma ctDNA biomarker profiling in addition to their standard-of-care therapy and disease surveillance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known or suspected colorectal adenocarcinoma (Stage I to IVA disease)
- •Planning to undergo or has undergone a surgical resection for suspected adenocarcinoma of the colon or rectum with curative intent.
- •18 years old or older
- •Willing and able to provide informed consent
- •Willing to have additional blood samples collected during routine surveillance visits
排除标准
- •Not willing to have additional blood samples collected
- •Pathology that is not consistent with colorectal adenocarcinoma
结局指标
主要结局
Recurrence-Free Survival
时间窗: 2 years
Recurrence-Free Survival as assessed by standard radiographic imaging, measured from the day of completion of definitive treatment to first radiographic recurrence or death
次要结局
- Sensitivity(2 years)
- Positive Predictive Value(2 years)
- Specificity(2 years)
研究者
研究点 (20)
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