Evaluating the Prognostic Capability of ctDNA as a Biomarker in Pancreatic Cancer Patients Undergoing Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- Number of patients with circulating tumor DNA (ctDNA) levels as not detectable in their blood compared to number of patients with ctDNA detected.
研究概览
简要总结
For patients who have been diagnosed with pancreatic cancer that has not spread outside of the pancreas and nearby lymph nodes. The purpose of this research study is to understand if we are able to detect pancreatic cancer DNA in the blood stream before, during, and after treatment.
详细描述
Cancer DNA in the blood stream is called circulating tumor DNA or ctDNA. The presence or absence of pancreatic cancer ctDNA in the blood stream may help clinicians to better understand pancreatic cancer behavior in response to specific treatments, like chemotherapy and surgery. Understanding how treatment alters the ctDNA can help future patients diagnosed with pancreatic cancer. The presence or absence of ctDNA or the clearance of ctDNA after treatment may help to guide further treatment decisions for cancer patients after surgery.
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
- •Biopsy or cytology proven adenocarcinoma of the pancreas
- •No clinical evidence of metastatic disease on imaging
- •Age 18 or older
- •Receiving chemotherapy for non-metastatic pancreatic cancer
排除标准
- •Biopsy proven metastatic disease
结局指标
主要结局
Number of patients with circulating tumor DNA (ctDNA) levels as not detectable in their blood compared to number of patients with ctDNA detected.
时间窗: 3 months
Utilizing Tempus, a commercial laboratory ctDNA genetic profile panel investigators will analyze the number of patients who had detectable ctDNA in their blood prior to neoadjuvant chemotherapy who then had no detectable ctDNA after their chemotherapy treatment.
次要结局
- Investigators will look for statistically significant correlations of ctDNA blood levels with clinical treatment responses of tumor grades, CA 19-9 units/milliliter blood level, and radiologic response by RECIST categories of complete response.(12 months)