RecruitingNCT05052671

ctDNA Assay in Patients With Resectable Pancreatic Cancer

Application of ctDNA Assay in the Neoadjuvant and Adjuvant Chemotherapy Setting in Patients With Resectable Pancreatic Cancer


Sponsor

University of Oklahoma

Enrollment

50 participants

Start Date

May 25, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria7

  • Newly diagnosed exocrine pancreatic cancer with either pathology or radiology imaging suggestive of adenocarcinoma
  • Resectable/Borderline Resectable Pancreatic cancer as defined by the NCCN guidelines
  • ≥ 18 years old at the time of informed consent
  • ECOG Performance Status 0 or 1
  • Patients who are candidates for neoadjuvant chemo/chemoradiotherapy or upfront surgery are eligible for the study.
  • Ability to provide written informed consent and HIPAA authorization
  • Patients must have a life expectancy of at least 6 months

Exclusion Criteria4

  • Patients with pancreatic malignant tumor histologically confirmed as neuroendocrine or any other type of malignancies
  • Positive pregnancy test, pregnant, or breastfeeding
  • Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study
  • Locally advanced or metastatic disease

Locations(2)

University of Oklahoma

Oklahoma City, Oklahoma, United States

Stephenson Cancer Center- Tulsa

Tulsa, Oklahoma, United States

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NCT05052671


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