NCT07122466进行中（未招募）不适用
Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy in Patients With Advanced Pancreatic Cancer: a Prospective, Observational 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
- 24
- 试验地点
- 1
- 主要终点
- First follow-up imaging assessment
研究概览
简要总结
This is a study that aims to understand whether a blood test measuring tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA) shows a similar response as observed by a follow-up CT scan. To study this question, ctDNA will be measured at the same times as CT scans (just before the start of treatment, as well as 2 months after), and the response measured by the ctDNA change will be compared to the response seen on the changes between the CT scans. The goal is to make sure that ctDNA response correlates well with CT scan response measurement.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Prior/Concurrent Therapy Criteria
- •Patients must be initiating a new treatment regimen for pancreatic cancer at the time of their initiation in the study
- •Patients must have cytologic or histologic confirmation of pancreatic cancer
- •Patients must have measurable radiographic evidence of metastatic disease
- •Patients must be ≥18 years of age
- •Patients must have an ECOG Performance Status 0-
- •Patients must have adequate organ function for delivery of chemotherapy as evidenced by the following: Hgb ≥8 g/dL, platelets ≥ 75
- •Patients must not have renal dysfunction that would prevent administration of IV contrast for radiographic assessment.
- •Regulatory Criteria
- •Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines.
- •Patients of all races, genders, & ethnicities are eligible.
排除标准
- •No exclusion criteria.
结局指标
主要结局
First follow-up imaging assessment
时间窗: 2 months
Compare first follow-up imaging assessment at 2 months with tumor response as assessed by ctDNA level change from baseline
次要结局
- ctDNA Assessment Comparison(2 months)
- Compare Signatera ctDNA test(6 months)
- ctDNA, CA19-9, & CEA Response(6 months)
研究者
研究点 (1)
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