A Cohort Study on Screening and Follow-up of High-risk Population of Pancreatic Cancer Based on Endoscopic Ultrasonography
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 900
- 主要终点
- Number of Participants with T1 PDAC
研究概览
简要总结
Study objective: The purpose of this study is to establish a prospective follow-up cohort of high-risk groups of pancreatic cancer, screen early pancreatic cancer through EUS and other means according to the existing clinical process, and evaluate each risk factors. And to prospectively collect biological samples to find molecular markers for early diagnosis of pancreatic cancer.
Study design: This is a real world, multicenter, prospective, observational cohort study.
详细描述
This study intends to conduct pancreatic MR screening for the high-risk population of pancreatic cancer who meet the requirements and voluntarily participate in this study (see eligibility criteria), and retain baseline information and peripheral blood, dental plaque and stool samples.
I. For patients with solid mass of the pancreas, continue diagnosis and treatment according to the routine clinical path.
II. For patients with MPD dilatation but no clear solid pancreatic mass, EUS examination should be performed after excluding contraindications. During EUS, duodenal fluid samples were collected.
III. If solid mass is found in EUS, FNA shall be performed. If the pathological examination is positive, the patient shall be diagnosed with PDAC and treated according to the clinical routine path of PDAC. If the pathological biopsy sample is negative, repeat FNA after an appropriate interval (1 to 3 months later).
IV. If no solid mass is found in EUS, follow up the patient every 6-12 months for EUS and/or MR examination.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •From the beginning of the study to the end of the study, the 18-80 year old patients who were admitted to Peking Union Medical College Hospital and related research centers and who met the high-risk population of pancreatic cancer understood and were willing to participate in the study and signed the informed consent form.
- •In this study, the high-risk population of pancreatic cancer is defined as patients who meet any of the following conditions:
- •A. Patients with previous history of pancreatitis (acute or chronic).
- •B. Patients with pancreatic cancer related genetic background, including immediate relatives with a family history of pancreatic cancer. Or genetic syndrome related to pancreatic cancer. [including hereditary breast cancer ovarian cancer syndrome (HBOCS), carney complex (CNC), familial adenomatous polyps (FAP), hereditary diffuse gastric cancer syndrome (HDGC), juvenile polyposis (JPS), cutaneous malignant melanoma (CMM), hereditary papillary renal cell carcinoma (HPRCC) and Lynch syndrome]
- •C. Patients with continuous or progressive increase of CA19-9 and CEA.
- •D. Patients with potential malignant pancreatic tumors, including mucinous cystic tumor (MCN) and intraductal papillary myxoma of the pancreas (IPMN).
- •E. Newly diagnosed patients with diabetes (within 3 years after diagnosis of diabetes).
- •F. Other patients who are considered as having high risk factors for pancreatic cancer.
排除标准
- •A. Those who are not suitable for endoscopic examination, including but not limited to: poor general condition, serious heart and lung disease, and difficult to tolerate the examination; coagulation disorders; platelets <50 × 10^9/L；those who are not suitable for endoscopic examination after interview by an endoscopic physician.
- •B. The patient or family member could not understand the conditions and objectives of this study.
结局指标
主要结局
Number of Participants with T1 PDAC
时间窗: 5 years
Patients found with early stage PDAC, which means tumor size \< 2cm.
Number of Participants with no clear pancreas lesions
时间窗: 5 years
Patients found with no clear pancreas lesions during 5 years follow-up.
次要结局
- Number of Participants with other stages of PDAC(5 years)
- Number of Participants with autoimmune pancreatitis(5 years)
- Number of Participants with other pancreas diseases(5 years)
- Number of Participants with IPMN(5 years)
- Number of Participants with chronic pancreatitis(5 years)
研究者
Wu Xi
associate professor
Peking Union Medical College Hospital