Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT04726956
Eligibility Criteria:
General Inclusion Criteria
1. Age ≥ 18 years old;
2. Sign the informed consent form voluntarily;
3. Not a patient in the intensive care unit;
2\. Patients with pancreatic ductal adenocarcinoma (PDAC group)
1. Two or more imaging studies (ultrasound, CT, MRI) found pancreatic tumors before operation, after surgical resection, intraoperative frozen pathology and postoperative pathology were clearly diagnosed as PDAC by 2 experienced pathologists, or diagnosed as pancreatic ductal adenocarcinoma by preoperative needle biopsy；
2. No other treatments such as radiotherapy or chemotherapy have been taken before the operation.
3\. Benign disease group (Benign group)
1. Diagnosis of pancreatic intraductal papillary mucinous tumor (IPMN), mucinous cystadenoma or pancreas cyst based on clinical manifestations, clinical examinations, medical imagings (ultrasound/CT/MRI/ERCP), biopsy, and pathology
2. No relevant surgical treatment;
4\. Healthy donors (Healthy group)
1. Healthy donors undergoing medical examinations at the above research centers;
2. Healthy donors of similar age without any benign or malignant diseases.
Exclusion Criteria:
1\. PDAC group:
1. Patients who have undergone radiotherapy, chemotherapy and other tumor-related treatments before surgery;
2. Patients with non-primary pancreatic cancer;
3. Patients undergoing secondary operations;
4. Infected with HIV or AIDS related diseases;
5. Diagnosed as chronic or acute gastroenteritis;
6. Pregnant women;
7. Other situations that are not suitable for this research; 2. Benign group
(1) Patients who have undergone related surgical treatment in other hospitals; (2) Patients with a history of malignant tumors; 3. Healthy group:
1. Patients with a history of tumor;
2. Tumors found in medical examinations;
3. History of hepatitis B or C;
4. A history of acute or chronic gastroenteritis, cholecystitis, and cholangitis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04726956
Study Brief:
Protocol Section:
NCT04726956