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

Last updated: October 14, 2024
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Overall Status: Completed

Phase

N/A

Condition

Pancreatic Disorders

Pancreatic Cancer

Adenocarcinoma

Treatment

N/A

Clinical Study ID

NCT04726956
SHLTQC-3
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

General Inclusion Criteria

  1. Age ≥ 18 years old;

  2. Sign the informed consent form voluntarily;

  3. Not a patient in the intensive care unit;

  4. Patients with pancreatic ductal adenocarcinoma (PDAC group)

  5. Two or more imaging studies (ultrasound, CT, MRI) found pancreatic tumors beforeoperation, after surgical resection, intraoperative frozen pathology andpostoperative pathology were clearly diagnosed as PDAC by 2 experiencedpathologists, or diagnosed as pancreatic ductal adenocarcinoma by preoperativeneedle biopsy;

  6. No other treatments such as radiotherapy or chemotherapy have been taken before theoperation.

  7. Benign disease group (Benign group)

  8. Diagnosis of pancreatic intraductal papillary mucinous tumor (IPMN), mucinouscystadenoma or pancreas cyst based on clinical manifestations, clinicalexaminations, medical imagings (ultrasound/CT/MRI/ERCP), biopsy, and pathology

  9. No relevant surgical treatment;

  10. Healthy donors (Healthy group)

  11. Healthy donors undergoing medical examinations at the above research centers;

  12. Healthy donors of similar age without any benign or malignant diseases.

Exclusion

Exclusion Criteria:

  1. PDAC group:

  2. Patients who have undergone radiotherapy, chemotherapy and other tumor-relatedtreatments before surgery;

  3. Patients with non-primary pancreatic cancer;

  4. Patients undergoing secondary operations;

  5. Infected with HIV or AIDS related diseases;

  6. Diagnosed as chronic or acute gastroenteritis;

  7. Pregnant women;

  8. 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 Design

Total Participants: 258
Study Start date:
February 01, 2021
Estimated Completion Date:
February 01, 2022

Connect with a study center

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

    Shanghai, Shanghai 200080
    China

    Site Not Available

  • Changhai Hospital of Shanghai

    Shanghai,
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Site Not Available

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