NCT03432806进行中（未招募）不适用
Development of Novel Imaging and Laboratory Biomarkers to Monitor the Liver Pre-metastatic Niche and Guide Treatment of Colon Cancer: A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- successful isolation of exosomes
研究概览
简要总结
The purpose of this study is to explore novel ways of diagnosing colon cancer and predicting its propensity to spread to other organs such as the liver.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be undergoing one of the following procedures as part of their routine care in order to meet the inclusion criteria:
- •Operation for presumed stage I-IV colon cancer including colectomy, hepatectomy, or abdominal surgery (e.g. insertion of HAIP)
- •Colectomy for presumed benign or pre-malignant colon tumors (e.g. large nonneoplastic polyps or adenomas)
- •Open, laparoscopic, or robotic resections
- •≥18 years old
排除标准
- •Extrahepatic CRC metastasis
- •No preoperative portal venous phase CT scan performed up to two months prior to day of surgery Pathology demonstrating a malignant tumor other than colorectal adenocarcinoma.
- •Stage IV colon cancer with resectable hepatic disease undergoing hepatectomy with active primary colon tumor still in place (despite chemo-radiation therapy) and no plans for colectomy.
- •Receipt of experimental therapies for colon cancer (e.g. checkpoint inhibitors or novel targeted agents). Of note, approved targeted agents (such as anti-angiogenic agents, EGFR inhibitors etc) are not an exclusion criterion.
- •History of non-colonic malignancy w/in 5 years (except non-melanomatous skin cancer)
- •Colon cancer with microsatellite instability (MSI-high) if known preoperatively
- •Known hereditary colon cancer syndrome such as familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC)
- •Known liver disease (e.g. non-alcoholic steatohepatitis, cirrhosis, viral or other form of hepatitis, etc)
- •INR >2 or known clotting factor deficiency
- •Anticipated need for full anticoagulation during hospitalization
- •Receipt of medications that increase significantly the risk of bleeding after liver biopsy (at the surgeon"s discretion)
- •Intraoperative discovery of pathology that precludes the planned surgical resection or liver biopsy, or makes resection futile (such as peritoneal carcinomatosis or other extrahepatic metastatic disease)
- •Operating surgeon deems research interventions to be more than a minimal risk for the patient
结局指标
主要结局
successful isolation of exosomes
时间窗: 1 year
defined as isolation of at least 5μg of exosomal protein and reported as a binomial proportion with a 95% confidence interval.
次要结局
未报告次要终点
研究者
研究点 (4)
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