ctDNA Assay in Patients With Resectable Pancreatic Cancer
Recruiting · NCT05052671 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Oklahoma
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
2 locations listed across 1 US state.
- University of Oklahoma - Oklahoma City, Oklahoma, United States
- Stephenson Cancer Center- Tulsa - Tulsa, Oklahoma, United States