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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04726956
Enrollment
258
Registered
2021-01-27
Start date
2021-02-01
Completion date
2022-02-01
Last updated
2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

pancreatic ductal adenocarcinoma, CA199, AKR1B10

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.

Interventions

None listed

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime 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 donors1 week

Secondary

MeasureTime 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 donors1 week

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026