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临床试验/NCT04536220
NCT04536220招募中不适用

Establish a Diagnostic Model Based on Multiple Molecule Profiling and Certain Established Markers for Identification of Pancreatic Cancer

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Status of survival

研究概览

简要总结

Explore new markers based on portal venous blood sampling to establish novel diagnostic models for identification of malignant pancreatic mass.

详细描述

EUS-FNA combined cytology detection is an important method for clinical diagnosis of squamous cell carcinoma. However, due to factors such as sampling method, smear making, staining technique, lower levels of the pathologists and other factors, its diagnostic sensitivity is still not very satisfactory. Poor diagnostic efficacy usually means another puncture, longer hospital stay, more medications and a higher incidence of adverse events. Missed diagnosis continuously directly delays the treatment time of the disease and seriously affects the patient's prognosis. Therefore, how to use new technologies to improve the differential diagnosis efficiency of benign and malignant pancreatic occupants is the key to improving the prognosis of diabetic cancer patients.

The portal vein blood comes from the venous tract, including the blood flowing from the plasma to the liver. By collecting blood samples from the patient's portal vein, clinicians can separate more information from the patient. Studies have shown that the portal vein blood can be collected by ultrasound endoscopic puncture. This method is less traumatic, convenient and safe, and more information about the retinal tissue can be obtained. It is an important way to improve the efficiency of patient diagnosis. This study intends to use ultrasound endoscopic puncture technology to obtain portal vein blood, and use big data and ctDNA, metabolomics, exosomes and other different omics methods to screen the potential value of volume-occupying benign and malignant differential diagnosis markers in portal vein blood. Peripheral blood will simultaneously be collected to evaluate the efficacy of these newly developed markers.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-75 years,male or female
  • diagnosis or suspection of solid pancreatic mass based on previous imaging examination (ultrasonography, CT or MRI)
  • lesion diameter larger than 1 cm
  • signed informed consent letter

排除标准

  • pregnant female
  • Pancreatic cystic lesions
  • Anticoagulant/antiplatelet therapy cannot be suspended
  • unable or refuse to provide informed consent
  • Coagulopathy (platelet count < 50× 103/μL,international normalized ratio > 1.5)
  • Severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia
  • with history of mental disease
  • other medical conditions that are not suitable for EUS-FNA

结局指标

主要结局

Status of survival

时间窗: through study completion, an average of 1 year

To varify if the patients died becaused of malignant pancreatic cancer.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhaoshen Li

Prefessor of Department of Gastroenterology

Changhai Hospital

研究点 (1)

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