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

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Ductal Adenocarcinoma

• Study Type: Observational
• Enrollment (Actual): 258

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Changhai Hospital of Shanghai
  • Zhengzhou, China
    • The First Affiliated Hospital of Zhengzhou University
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The population included in the case group was patients with clinically and pathologically clear pancreatic ductal adenocarcinoma; and the population included in the benign group was patients with clinically and pathologically clear IPMN, mucinous cystadenoma, or pancreas cyst; and the population included in the control group was a healthy population without any benign or malignant diseases.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
case cohort; Pancreatic ductal adenocarcinoma patients (140)
control cohort; healthy donors (140)
Benign cohort; 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	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	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

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: pancreatic ductal adenocarcinoma; CA199; AKR1B10
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: SHLTQC-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No