About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
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.
Trial population
Patients with high risks for pancreas cancer in Peking Union Medical College Hospital and other related research centers in China.
Trial design
Cohort
Prospective
Treatments tested in this trial
Endoscopic ultrasound
DeviceUse endoscopic ultrasound to examine the pancreatic lesions.
EUS-Fine needle aspiration
Procedure/SurgeryIf solid mass of pancreas was found during EUS, EUS-FNA shall be conducted for diagnosis.
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants with T1 PDAC
Patients found with early stage PDAC, which means tumor size \< 2cm.
Number of Participants with no clear pancreas lesions
Patients found with no clear pancreas lesions during 5 years follow-up.
Secondary outcomes
Number of Participants with other stages of PDAC
Patients found with any other stages of PDAC except from T1 PDAC.
Number of Participants with IPMN
Patients found with IPMN during the study.
Number of Participants with chronic pancreatitis
Patients found with chronic pancreatitis during the study.
Number of Participants with autoimmune pancreatitis
Patients found with autoimmune pancreatitis during the study.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking Union Medical College Hospital
Lead sponsor
Beijing Hospital
Collaborator
Tongji Hospital
Collaborator
The First Affiliated Hospital of Xiamen University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: