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Completed

NCT Number: NCT04726956

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

General Inclusion Criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

    Time frame: 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

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 27, 2021
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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