NCT02250638已完成不适用
A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients With Pancreatic Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 7
- 主要终点
- A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients with Pancreatic Cancer
研究概览
简要总结
To obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of pancreatic cancer.
详细描述
The study objectives are described below:
- Obtain serum and plasma specimens longitudinally collected from approximately 140 subjects diagnosed with pancreatic cancer and are about to or are currently undergoing treatment and follow-up. Specimens will be used to evaluate CA 19-9 assays, currently under development, as an aid for monitoring recurrence or progressive disease.
- To store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of IVDs, including additional CA 19-9 assays, for monitoring the course of disease and therapy in subjects diagnosed 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
- •Males and females, age≥ 18 years
- •Histologic/pathologic confirmation of exocrine pancreatic cancer
- •Any stage of disease: Newly diagnosed, stable, disease progression
- •Any treatment time point: Treatment naïve, currently receiving or completed therapy for pancreatic cancer including active monitoring.
- •Individuals with a history of malignant disease other than pancreatic cancer that was resected greater than 5 years ago and are currently in remission are eligible.
- •Life expectancy greater than 6 months
- •Able to understand and willing to provide informed consent
排除标准
- •Males and females, age <18 years
- •No histologic/pathologic confirmation of exocrine pancreatic cancer
- •Life expectancy less than 6 months
- •Any concurrent malignancy other than basal or squamous cell skin cancers or in-situ cervical cancer.
- •Unable to provide informed consent
结局指标
主要结局
A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients with Pancreatic Cancer
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (7)
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