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Circulating Tumor DNA as a Prognostic Marker in Patients With Pancreatic Cancer


2017-05-12


2020-09-30


2021-03-31


100

Study Overview

Circulating Tumor DNA as a Prognostic Marker in Patients With Pancreatic Cancer

The aim of this study is to determine the usefulness of circulating tumor DNA as a prognostic factor in patients with pancreatic cancer.

There is currently no strong prognostic factor in pancreatic cancer. K-ras is the most commonly mutated gene in pancreatic cancer, with a mutation rate of 75% to 95%. These high mutation rates are expected to be useful for diagnosis and prognostic factors in future. Currently, K-ras mutation tests are often performed in tissues, and there are various limitations, in particular, limited obtaining of sufficient tissues. In this regard, analyzing the prognosis of pancreatic cancer through non-invasive blood testing has significant advantages. And Prognosis analysis through blood tests can be done through blood circulating tumor DNA. The relationship between prognosis and blood circulating tumor DNA has already been studied in other cancers such as colorectal cancer, and there have been several studies in pancreatic cancer. However, there are not many research results yet, and there are cases in which the results differ from study to study. Therefore, the purpose of this study is to compare the overall survival of patients with pancreatic cancer diagnosed by EUS-FNA according to the presence and amount of blood circulating tumor DNA with K-ras mutation.

  • Pancreatic Cancer
    • 1704-108-847

    Study Record Dates

    These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

    Study Registration Dates Results Reporting Dates Study Record Updates

    2017-07-11  

    N/A  

    2018-02-01  

    2017-07-11  

    N/A  

    2018-02-05  

    2017-07-12  

    N/A  

    2018-02  

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    Design Details

    Primary Purpose:
    N/A


    Allocation:
    N/A


    Interventional Model:
    N/A


    Masking:
    N/A


    Arms and Interventions

    Participant Group/ArmIntervention/Treatment
    Primary Outcome MeasuresMeasure DescriptionTime Frame
    Overall survival rateComparison of overall survival rates between patients with and without blood-circulating tumor DNA48 months
    Secondary Outcome MeasuresMeasure DescriptionTime Frame
    Overall survival rate according to the amount of blood circulating tumor DNAOverall survival rate according to the amount of blood circulating tumor DNA48mo
    K-ras mutationThe concordance rate of K-ras mutation in EUS-FNA specimen and K-ras mutation in blood circulating tumor DNA48 months
    Overall survival rate (EUS-FNA)Overall survival rate with or without K-ras mutation of EUS-FNA specimen48 months
    Overall survival rate (K-ras mutation type, circulating tumor DNA)Overall survival rate according to K-ras mutation type in blood circulating tumor DNA48 months
    Overall survival rate (K-ras mutation type, EUS-FNA)Overall survival rate according to K-ras mutation type in EUS-FNA specimen48 months

    Contacts and Locations

    This section provides the contact details for those conducting the study, and information on where this study is being conducted.

    Study Contact

    Name: Young Hoon Choi, MD

    Phone Number: 82-2-2072-2228

    Email: crzyzs@naver.com

    Study Contact Backup

    Name: Ji Kon Ryu, MD, PhD

    Phone Number: 82-2-2072-2228

    Email: jkryu@snu.ac.kr

    Participation Criteria

    Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

    Ages Eligible for Study:
    ALL

    Sexes Eligible for Study:
    18 Years

    Accepts Healthy Volunteers:

      Inclusion Criteria:

    • Patients diagnosed with pancreatic cancer through EUS-FNA.

    • Exclusion Criteria:

    • Severe mental illness
    • Severe co-morbidity (ESRD, Advanced COPD, severe Heart failure, poorly controlled blood sugar)
    • Pregnancy
    • Patients who have received chemotherapy
    • Coagulopathy

    Collaborators and Investigators

    This is where you will find people and organizations involved with this study.


      • PRINCIPAL_INVESTIGATOR: Ji Kon Ryu, MD, PhD, Seoul National University Hospital

      Publications

      The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

      General Publications

      No publications available