NCT05379907撤回不适用
Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Impact of SIGNATERA™ on treatment decisions
研究概览
简要总结
The purpose of this study is to collect information about treatment recommendations based on ctDNA testing and whether treatment changes based on ctDNA information result in better outcomes for patients with pancreatic cancer.
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
- •18 years of age or older
- •Resectable or borderline resectable pancreatic adenocarcinoma per NCNN guidelines
- •No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer.
- •ECOG performance status ≤ 1
- •Clinically eligible for chemotherapy
- •Able to tolerate collection of up to 20 mL of blood via venipuncture for research blood draw
- •Has residual FFPE specimen available for submission to Natera
- •Able to read, understand and provide written informed consent
- •Willing and able to comply with the study requirements
排除标准
- •Pregnant or breastfeeding
- •Radiologic evidence of distant metastases
- •Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer
- •Prior initiation of chemotherapy, radiation therapy, or surgery for pancreatic cancer
- •Neuropathy > grade 2
- •History of bone marrow or organ transplant
- •Blood transfusion within 1 month of enrollment
- •Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
- •Serious medical condition that may adversely affect ability to participate in the study
结局指标
主要结局
Impact of SIGNATERA™ on treatment decisions
时间窗: 2 years
Examine the impact of SIGNATERA™ on treatment decisions as determined by physician questionnaires
次要结局
- Frequency of positive SIGNATERA™ ctDNA testing(2 years)
- Overall survival of patients managed with SIGNATERA™ ctDNA data(2 years)
- Patient satisfaction of SIGNATERA™ ctDNA on treatment recommendations(2 years)
- Progression-free survival of patients managed with SIGNATERA™ ctDNA data(2 years)
研究者
研究点 (1)
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