Construction of Molecular Diagnostic Marker Models for Pancreatic Cystic Tumors Based on CfDNA Methylation Sequencing and Proteomic Analysis of Pancreatic Cystic Fluid Samples
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Types and concentrations of cfDNA and proteins contained in the vesicular fluid
研究概览
简要总结
The goal of this observational study is to test in patients with cystic tumor of pancreas. The main questions it aims to answer are:
Screening of molecular diagnostic markers for pancreatic cystic tumors by cfDNA methylation sequencing of pancreatic cystic fluid and proteomic assays to distinguish benign from malignant and mucinous/non-mucinous, correlate with pathological features, and find molecular features associated with the degree of malignancy.
Participants will Provide post-operative cyst fluid specimens.
详细描述
Patients with pancreatic cystic tumors were divided into control, mucinous tumor and non-mucinous tumor groups, and cfDNA molecules and protein molecules that were significantly altered between different groups were found by cfDNA methylation sequencing of pancreatic cystic fluid and proteomic detection techniques. Multi-omics analysis was performed to construct a more efficient molecular diagnostic marker model. Correlating models with pathological features to find molecular features associated with the degree of malignancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Subjects are ≥ 18 years old, regardless of gender;
- •Preoperative imaging examination (EUS, CT, MRI) diagnosed cystic mass of pancreas and suspected cystic tumor;
- •Subjects voluntarily accepted radical resection of pancreatic cystic tumors;
- •Subjects or family members voluntarily sign the informed consent form for clinical research.
排除标准
- •The excised sample does not contain cystic components, or the cystic fluid cannot be collected;
- •Receive tumor-related treatment (radiotherapy, chemotherapy, immunotherapy, etc.) before operation;
- •Receive antibiotic treatment within 1 week before operation;
- •Subjects refused to accept radical resection of pancreatic cystic tumor, or had any situation that they could not accept radical resection of pancreatic cystic tumor;
- •The subjects or their families refused to sign the informed consent form for clinical research.
结局指标
主要结局
Types and concentrations of cfDNA and proteins contained in the vesicular fluid
时间窗: 2023-11-31
Identification of protein and circulating gene methylation species in cyst fluid and quantification of their concentrations using mass spectrometry. Characterize cfDNA methylation and proteomics of cyst fluid in patients with pancreatic cystic neoplasm (PCN).
次要结局
- Development of a progressive benign malignancy prediction model(2023-11-31)
- Establishing a model for the identification of mucus and non-mucus(2023-11-31)
- Establishment of a diagnostic model for cystic tumors of the pancreas(2023-11-31)
研究者
Zhaoshen Li
Director of Gastroenterology Department of Changhai Hospital
Changhai Hospital