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

Shanghai Jiao Tong University

Status: Completed

Conditions: Pancreatic Ductal Adenocarcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT04726956

SHLTQC-3

Details and patient eligibility

About

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.

Enrollment: 258 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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;

4. Patients with pancreatic ductal adenocarcinoma (PDAC group)

5. 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；

6. No other treatments such as radiotherapy or chemotherapy have been taken before the operation.

7. Benign disease group (Benign group)

8. 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

9. No relevant surgical treatment;

10. Healthy donors (Healthy group)

11. Healthy donors undergoing medical examinations at the above research centers;

12. Healthy donors of similar age without any benign or malignant diseases.

Exclusion Criteria:

1. PDAC group:

2. Patients who have undergone radiotherapy, chemotherapy and other tumor-related treatments before surgery;

3. Patients with non-primary pancreatic cancer;

4. Patients undergoing secondary operations;

5. Infected with HIV or AIDS related diseases;

6. Diagnosed as chronic or acute gastroenteritis;

7. Pregnant women;

8. 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.

Trial design

258 participants in 3 patient groups

case cohort

Description:

Pancreatic ductal adenocarcinoma patients (140)

control cohort

Description:

healthy donors (140)

Benign cohort

Description:

patients with Intraductal papillary mucinous tumor of the pancreas (IPMN), mucinous cystadenoma, or pancreatic cyst (30)