This phase I trial assesses the role of biomarker testing (circulating tumor-derived deoxyribonucleic acid [ctDNA] assay) in improving care for patients with pancreatic cancer that can be removed by surgery (resectable) and undergoing surgery and chemotherapy (treatment with curative intent). ctDNA refers to freely circulating tumor DNA fragments found in the blood plasma. This study determines the proportion of positive ctDNA before and after treatment (surgery and chemotherapy) 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05052671.
Locations matching your search criteria
United States
Oklahoma
Oklahoma City
University of Oklahoma Health Sciences CenterStatus: Active
Contact: Sagila George
Phone: 405-271-4022
PRIMARY OBJECTIVES:
I. Proportion of ctDNA positive in patients with resectable pancreatic cancer.
II. Progression free survival (PFS) in ctDNA positive versus ctDNA negative.
SECONDARY OBJECTIVES:
I. Median time from positive ctDNA to negative ctDNA in patients with pancreatic cancer undergoing surgical resection and adjuvant chemotherapy.
II. Median time from any positive KRAS, CDKN2A, SMAD4, or TP53 genes to become negative.
III. Overall survival (OS) in ctDNA positive versus ctDNA negative.
OUTLINE:
Patients undergo blood collection for plasma ctDNA testing at baseline, 2-4 months from the start of neoadjuvant chemotherapy, pre-operation, and 4-6 weeks post-surgery. Patients then undergo blood collection with plasma ctDNA testing every 4 or 8 weeks for 24 weeks then every 3 months for an additional 2 years. Patients also undergo computed tomography (CT) throughout the study.
Lead OrganizationUniversity of Oklahoma Health Sciences Center
Principal InvestigatorSagila George
