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

NCT ID: NCT04726956

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 258 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-02-01

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

case cohort

Pancreatic ductal adenocarcinoma patients (140)

No interventions assigned to this group

control cohort

healthy donors (140)

No interventions assigned to this group

Benign cohort

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Lin Zhong

Director of Hepatobiliary and Pancreatic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Changhai Hospital of Shanghai

Shanghai, , China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Countries

China

Other Identifiers

SHLTQC-3

Identifier Type: -

Identifier Source: org_study_id