A Combination of AKR1B10 and CA19-9 Improves the Diagnosis of PDAC

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to clarify the diagnostic significance of AKR1B10 in patients with pancreatic ductal adenocarcinoma, and to combine with CA19-9 to improve the diagnosis rate of pancreatic ductal adenocarcinoma.

Official Title
-----------------
A Combination of AKR1B10 and CA19-9 Improves the Diagnosis of Pancreatic Ductal Adenocarcinoma：A Multicenter Study

Conditions
-----------------
Pancreatic Ductal Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
General Inclusion Criteria Age ≥ 18 years old; Sign the informed consent form voluntarily; Not a patient in the intensive care unit; 2. Patients with pancreatic ductal adenocarcinoma (PDAC group) 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； No other treatments such as radiotherapy or chemotherapy have been taken before the operation. 3. Benign disease group (Benign group) 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 No relevant surgical treatment; 4. Healthy donors (Healthy group) Healthy donors undergoing medical examinations at the above research centers; Healthy donors of similar age without any benign or malignant diseases. Exclusion Criteria: 1. PDAC group: Patients who have undergone radiotherapy, chemotherapy and other tumor-related treatments before surgery; Patients with non-primary pancreatic cancer; Patients undergoing secondary operations; Infected with HIV or AIDS related diseases; Diagnosed as chronic or acute gastroenteritis; Pregnant women; 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: Patients with a history of tumor; Tumors found in medical examinations; History of hepatitis B or C; A history of acute or chronic gastroenteritis, cholecystitis, and cholangitis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| case cohort<br>Pancreatic ductal adenocarcinoma patients (140) | |
| control cohort<br>healthy donors (140) | |
| Benign cohort<br>patients with Intraductal papillary mucinous tumor of the pancreas (IPMN), mucinous cystadenoma, or pancreatic cyst (30) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CA199 and AKR1B10 were detected in the sera of PDAC patients and Benign patients before surgery, as well as in the sera of healthy donors |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CA125, CEA, and AFP were detected in the sera of PDAC and Benign patients before surgery, as well as in the sera of healthy donors |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic ductal adenocarcinoma, CA199, AKR1B10