Molecular Stethoscope for Colon Cancer Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 主要终点
- Determining sensitivity of assay in known cancer patients
研究概览
简要总结
The study aims to provide a more complete characterization and understanding of the genetic causes of and tumor DNA detection potential in colorectal cancer. Ultimately findings of this study will be used to develop early detection tests for colorectal cancer that are minimally invasive (based on a blood test). It is hoped that reliable, minimally invasive, early detection methods will lead to improved screening rates, increased screening safety, longer colorectal cancer survival, and overall cost savings.
In order to assess the test's ability to detect tumor DNA, 25 participants with known colorectal cancer who will be undergoing surgical resection of the colon as part of their clinical care will be recruited. The investigators will collect blood from participants prior to surgery, tumor and normal tissue removed during surgery, a series of blood samples after surgery for up to one year and relevant medical records. DNA variants identified in blood will be compared against tissue samples. Serial samples will be analyzed to assess the variance in amount of circulating tumor DNA across time with standard treatment.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colorectal cancer sent for surgical colonic resection (all stages) OR
- •High risk adenoma sent for surgical colonic resection
排除标准
- •Chemotherapy before surgical treatment
- •Invasive procedure resulting in damage to tissue (e.g., surgery, biopsy, thermal ablation) in the 7 days prior to baseline (pre-surgical) blood collection
- •Radiation therapy before surgical treatment
- •Bone marrow transplant
结局指标
主要结局
Determining sensitivity of assay in known cancer patients
时间窗: 2 years
The sensitivity (% positive out of all diseased patients) of circulating tumor DNA detection from the blood samples will be calculated against the gold standard of surgical pathology reports in this pilot group of patients with known colorectal cancer.
次要结局
未报告次要终点
研究者
Eric Topol, MD
Director, Scripps Translational Science Institute
Scripps Translational Science Institute