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

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04726956
• Other study ID #: SHLTQC-3
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: July 2022
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Locations

Country	Name	City	State
China	Changhai Hospital of Shanghai	Shanghai
China	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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