Status:

COMPLETED

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

Lead Sponsor:

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Conditions:

Pancreatic Ductal Adenocarcinoma

Eligibility:

All Genders

18-90 years

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...

Eligibility Criteria

Inclusion

  • General Inclusion Criteria
  • Age ≥ 18 years old;
  • Sign the informed consent form voluntarily;
  • Not a patient in the intensive care unit;
  • 2\. 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.
  • 3\. 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;
  • 4\. 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.
  • Exclusion Criteria:
  • 1\. 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.

Exclusion

    Key Trial Info

    Start Date :

    February 1 2021

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2022

    Estimated Enrollment :

    258 Patients enrolled

    Trial Details

    Trial ID

    NCT04726956

    Start Date

    February 1 2021

    End Date

    February 1 2022

    Last Update

    October 16 2024

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, China, 200080

    2

    Changhai Hospital of Shanghai

    Shanghai, China

    3

    The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, China