ctDNA Assay in Patients With Resectable Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

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.

Primary outcome public domain (ClinicalTrials.gov)

ctDNA Positivity in Patients with Resectable Pancreatic Cancer. Determine the proportion of ct DNA positivity in patients with resectable pancreatic cancer. Time frame: Baseline.

Primary outcome public domain (ClinicalTrials.gov)

Progression free survival (PFS). Determine PFS in ctDNA positive versus ctDNA negative patients. Time frame: 2 years.

Secondary outcome public domain (ClinicalTrials.gov)

Conversion time from ctDNA negative to positive after surgical resection.. Time frame: 2 years.

Secondary outcome public domain (ClinicalTrials.gov)

Median time for select genes to convert from positive to negative.. Time frame: 2 years.

Secondary outcome public domain (ClinicalTrials.gov)

Overall survival (OS) in ctDNA positive versus ctDNA negative.. Time frame: 2 years.

Eligibility public domain (ClinicalTrials.gov)

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

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 50 participants (estimated).