The Influence of Secretin Stimulated Pancreatic Secretion on Circulating Tumor DNA Expression in Patients With Pancreatic Ductal Adenocarcinoma: The Role of Biomarkers in Determining the Prognosis of Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Plasmatic level of circulating tumor DNA
研究概览
简要总结
The goal of this study is to assess the influence of pancreatic secretion stimulation by intravenously administered secretin on circulating tumor DNA in patients with pancreatic ductal adenocarcinoma. Additional aim of the study is to analyse a role of specific biomarkers in determining the prognosis of this disease. The main question o answer is:
Does intravenous secretin administration potentiate the release of circulating tumor DNA in patients with pancreatis ductal adenocarcinoma?
Additional question is:
Is there a biomarker specific and sensitive enough to help to predict the prognosis and the at the time status of the disease?
Participants scheduled for surgical treament due to pancreatic ductal adenocarcinoma will be included and stimulated with intravenously administered secretin, their peripheral blood samples will then be analyzed for ctDNA levels.
详细描述
Background Pancreatic ductal adenocarcinoma (PDAC) is an aggressive oncological disease with a poor prognosis and low survival rate. Due to its biological nature, it is generally challenging to accomplish early diagnostics and therefore to achieve successful therapeutic results.
Recently, many trials and studies worldwide aim at better understanding of tumor biology and providing a novel tool for diagnostics, disease monitoring and developing a targeted therapy. One of the subjects of interest happen to be the so-called liquid biopsies.
Isolation of biomarkers such as miRNA, tumor suppressor genes or amino acids from these biopsies, their analysis, quantification and incorporation into clinical oncology represents a complex issue where further research is highly required. Subjects, materials, methods A crucial prerequisite for biomarker analysis is a sufficient amount of genetic information. In our study, the effect of intravenous secretin administration on ctDNA release in patients with PDAC will be analysed. More than 90% KRAS mutation rate in patients with PDAC has been scientifically proven, therefore patients with positive KRAS mutation in their peripheral blood plasma and scheduled for surgical therapy will be included in the study.
Peripheral blood plasma of 36 patients with PDAC diagnosis will then be collected in specific intervals during the first two hours of the operation. Plasmatic levels of ctDNA in the samples will be quantified. A standardized panel of biomarkers will be designed and tested in patients with PDAC prior to surgery and in specific intervals after surgery. The results will be analyzed in correlation to minimal residual disease, survival rate and other indicators to determine the prognosis of the disease. Statistic evaluation will be done in cooperation with specialists experienced in bioinformatics and biomedical statistics.
Introduction:
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
- •patients diagnosed with pancreatic ductal adenocarcinoma
- •patients indicated for surgery by multidisciplinary tumor board
- •patients without previously administered chemotherapy
- •patients with previously administered chemotherapy
排除标准
- •patients diagnosed with pancreatic ductal adenocarcinoma, at the time indicated for different than surgical therapy
结局指标
主要结局
Plasmatic level of circulating tumor DNA
时间窗: During the surgery: 3, 8, 13, 18 minutes after secretin administration; 3, 6 and 12 months after surgery
ng/ml
次要结局
- Plasmatic levels of mRNA, miRNA, S100 proteins, siRNA, exoRNA.(During the surgery: 3, 8, 13, 18 minutes after secretin administration; 3, 6 and 12 months after surgery.)