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

NCT04726956 | Completed

• 1 other identifier: SHLTQC-3
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 3

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

Keywords

pancreatic ductal adenocarcinoma; CA199; AKR1B10

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 years old;
• Sign the informed consent form voluntarily;
• Not a patient in the intensive care unit;
• \. Patients with pancreatic ductal adenocarcinoma (PDAC group)
• 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；
• No other treatments such as radiotherapy or chemotherapy have been taken before the operation.
• \. Benign disease group (Benign group)
• 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
• No relevant surgical treatment;
• \. Healthy donors (Healthy group)
• Healthy donors undergoing medical examinations at the above research centers;
• Healthy donors of similar age without any benign or malignant diseases.

You may not qualify if:

• \. PDAC group:
• Patients who have undergone radiotherapy, chemotherapy and other tumor-related treatments before surgery;
• Patients with non-primary pancreatic cancer;
• Patients undergoing secondary operations;
• Infected with HIV or AIDS related diseases;
• Diagnosed as chronic or acute gastroenteritis;
• Pregnant women;
• 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:
• Patients with a history of tumor;
• Tumors found in medical examinations;
• History of hepatitis B or C;
• A history of acute or chronic gastroenteritis, cholecystitis, and cholangitis.

Sponsors & Collaborators

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

Study Sites (3)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200080, China

Location

Changhai Hospital of Shanghai

Shanghai, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hepatobiliary and Pancreatic Surgery

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 27, 2021
• Study Start: February 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: February 1, 2022
• Last Updated: October 16, 2024

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)