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Clinical Trial Record

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ctDNA Assay in Patients With Resectable Pancreatic Cancer

2022-05-25

2025-12

2027-12

50

Study Overview

ctDNA Assay in Patients With Resectable Pancreatic Cancer

The purpose of this study is to determine the proportion of positive ctDNA -freely circulating tumor DNA fragments found in the blood plasma- in patients with pancreatic cancer and to better understand the relationship between possible ctDNA biomarkers and patient survival. A successful study may provide preliminary evidence that helps improve future patient care through targeted diagnostics, prognosis, and/or treatment.

The objective of this study is to assess the role of serial ctDNA analysis as integrative biomarker in patients with resectable or borderline resectable pancreatic cancer undergoing treatment with curative intent. This is a single arm prospective tissue/blood collection from patients undergoing neoadjuvant treatment and Surgery as well as surveillance, plan to accrue up to 50 patients. Primary objective is to determine the proportion of ctDNA positive in patients with resectable pancreatic cancer and to evaluate the progression free survival (PFS) in subjects with ctDNA positive versus ctDNA negative. Patients who consent to the study will participate in pre-study exams and tests to find out if they can take part in the study. This includes, but is not limited to, a doctor's visit with medical history and physical evaluation, blood work, pregnancy test for those capable of becoming pregnant, and imaging tests. The study itself will include the patient's regular treatment for pancreatic cancer which may include 4 to 6 months of chemotherapy, chemo-radiation, surgery to remove pancreatic cancer, 24 weeks of post operative ctDNA surveillance and follow up for 2 years. Blood will be drawn at regular time points during this study for ctDNA detection. The tumor tissue at diagnosis will be collected to develop a personalized and tumor informed PCR test.

  • Pancreas Cancer
    • OU-SCC-ctDNA

    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

    2021-09-13  

    N/A  

    2025-02-21  

    2021-09-13  

    N/A  

    2025-02-24  

    2021-09-22  

    N/A  

    2025-02  

    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
    ctDNA Positivity in Patients with Resectable Pancreatic CancerDetermine the proportion of ct DNA positivity in patients with resectable pancreatic cancer.Baseline
    Progression free survival (PFS)Determine PFS in ctDNA positive versus ctDNA negative patients.2 years
    Secondary Outcome MeasuresMeasure DescriptionTime Frame
    Conversion time from ctDNA negative to positive after surgical resection.Median time from positive ctDNA to negative ctDNA in patients with pancreatic cancer undergoing surgical resection and adjuvant chemotherapy2 years
    Median time for select genes to convert from positive to negative.Median time from any positive KRAS, CDKN2A, SMAD4, or TP53 genes to become negative2 years
    Overall survival (OS) in ctDNA positive versus ctDNA negative.Comparison of overall survival rate of ctDNA positive versus ctDNA negative patients.2 years

    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: Lead Nurse

    Phone Number: 1-405-271-8777

    Email: SCC-IIT-office@ouhsc.edu

    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
      1. Newly diagnosed exocrine pancreatic cancer with either pathology or radiology imaging suggestive of adenocarcinoma 2. Resectable/Borderline Resectable Pancreatic cancer as defined by the NCCN guidelines 3. ≥ 18 years old at the time of informed consent 4. ECOG Performance Status 0 or 1 5. Patients who are candidates for neoadjuvant chemo/chemoradiotherapy or upfront surgery are eligible for the study. 6. Ability to provide written informed consent and HIPAA authorization 7. Patients must have a life expectancy of at least 6 months
      Exclusion Criteria
      1. Patients with pancreatic malignant tumor histologically confirmed as neuroendocrine or any other type of malignancies 2. Positive pregnancy test, pregnant, or breastfeeding 3. Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study 4. Locally advanced or metastatic disease

    Collaborators and Investigators

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

    • Natera, Inc.
    • PRINCIPAL_INVESTIGATOR: Sagila George, University of Oklahoma

    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

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