Evaluation of a Biomarker Panel for the Diagnosis and Prognosis of Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Investigational biomarker panel for diagnosis
研究概览
简要总结
This is a non-treatment, blood collection study to evaluate biomarker panels for the diagnosis and prognosis of pancreatic cancer.
详细描述
This is a non-treatment, blood collection study to evaluate biomarker panels for the diagnosis and prognosis of pancreatic cancer.
Study participants will be recruited by physician referral or from a list of clinical patients being evaluated for a potential pancreatic abnormality or for potential treatment of pancreatic cancer. Additionally, a surveillance cohort will be recruited among individuals who are being monitored for recurrence following surgical or medical treatment for pancreatic cancer.
Peripheral blood specimens will be collected from all participants at time of enrollment. Additional specimens may be collected from surveillance cohort participants no more frequently than once every 3 months as clinically indicated.
The specimens will be sent to a clinical lab for sTRA biomarker and CA19-9 analysis. Participants will be followed for 36 months to track clinical outcomes. The performance of the investigation biomarker for the diagnosis, prognosis, or surveillance of pancreatic cancer will be compared to the performance of CA19-9.
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
- •Diagnosis/Prognosis Cohort
- •Patients being evaluated for possible pancreatic abnormality, via additional radiological test (endoscopic ultrasound, abdominal CT scan), blood test (CA19-9), or other diagnostic procedure.
- •Patients being evaluated for medical or surgical treatment for pancreatic cancer or pancreatitis on the basis of previous clinical and radiological findings.
- •Surveillance Cohort
- •Patients being monitored or who will be monitored for potential recurrence of pancreatic cancer following surgical or medical treatment of pancreatic adenocarcinoma.
排除标准
- •The participant is unwilling or unable to provide written informed consent.
- •In the investigator's opinion, the participant is unsuitable for the study.
- •The participant does not speak English.
- •The participant is a prisoner.
- •The participant is known to be pregnant.
- •The participant is less than 18 years of age.
结局指标
主要结局
Investigational biomarker panel for diagnosis
时间窗: Enrollment
sTRA biomarker and CA 19-9 levels at enrollment
Diagnosis of adenocarcinoma of the pancreas
时间窗: Up to three years
Number of patients clinically diagnosed with pancreatic adenocarcinoma
次要结局
- Disease progression(Up to three years)
- Investigational biomarker panel for disease surveillance(Up to three years)