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NCT05621824
A Cohort Study on Screening and Follow-up of High-risk Population of PDAC Based on EUS
Conditions: Carcinoma, Pancreatic Ductal
Sex: All
Ages: 18 Years – 80 Years
Enrollment: 900
Sponsor: Peking Union Medical College Hospital
Summary
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.
Eligibility Criteria
Inclusion Criteria: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.Exclusion Criteria: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.
Source: ClinicalTrials.gov (NCT05621824). StuddyBuddy aggregates publicly available trial information.