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ctDNA Assay in Patients With Resectable Pancreatic Cancer

Sponsor
University of Oklahoma (Other)
Overall Status
Recruiting
CT.gov ID
NCT05052671
Collaborator
Natera, Inc. (Industry)
50
Enrollment
1
Location
42.3
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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, adjuvant chemotherapy 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Application of ctDNA Assay in the Neoadjuvant and Adjuvant Chemotherapy Setting in Patients With Resectable Pancreatic Cancer
    Actual Study Start Date :
    May 25, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. ctDNA Positivity in Patients with Resectable Pancreatic Cancer [Baseline]

      Determine the proportion of ct DNA positivity in patients with resectable pancreatic cancer.

    2. Progression free survival (PFS) [2 years]

      Determine PFS in ctDNA positive versus ctDNA negative patients.

    Secondary Outcome Measures

    1. Conversion time from ctDNA negative to positive after surgical resection. [2 years]

      Median time from positive ctDNA to negative ctDNA in patients with pancreatic cancer undergoing surgical resection and adjuvant chemotherapy

    2. Median time for select genes to convert from positive to negative. [2 years]

      Median time from any positive KRAS, CDKN2A, SMAD4, or TP53 genes to become negative

    3. Overall survival (OS) in ctDNA positive versus ctDNA negative. [2 years]

      Comparison of overall survival rate of ctDNA positive versus ctDNA negative patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Oklahoma Oklahoma City Oklahoma United States 73117

    Sponsors and Collaborators

    • University of Oklahoma
    • Natera, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oklahoma
    ClinicalTrials.gov Identifier:
    NCT05052671
    Other Study ID Numbers:
    • OU-SCC-ctDNA
    First Posted:
    Sep 22, 2021
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Jun 15, 2022