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

Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04726956
Collaborator
(none)
310
Enrollment
3
Locations
24
Anticipated Duration (Months)
103.3
Patients Per Site
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    310 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Combination of AKR1B10 and CA19-9 Improves the Diagnosis of Pancreatic Ductal Adenocarcinoma：A Multicenter Study
    Actual Study Start Date :
    Feb 1, 2021
    Anticipated Primary Completion Date :
    Feb 1, 2023
    Anticipated Study Completion Date :
    Feb 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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)

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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 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；

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

    7. Benign disease group (Benign group)

    8. 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

    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 Criteria:

    1. PDAC group:

    2. Patients who have undergone radiotherapy, chemotherapy and other tumor-related treatments 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200080
    2 Changhai Hospital of Shanghai Shanghai China
    3 The First Affiliated Hospital of Zhengzhou University Zhengzhou China

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lin Zhong, Director of Hepatobiliary and Pancreatic Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT04726956
    Other Study ID Numbers:
    • SHLTQC-3
    First Posted:
    Jan 27, 2021
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lin Zhong, Director of Hepatobiliary and Pancreatic Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
    pancreatic ductal adenocarcinoma
    CA199
    AKR1B10
    Additional relevant MeSH terms:
    Adenocarcinoma

    Study Results

    No Results Posted as of Jul 14, 2022