Blood test for tumor DNA in patients with pancreatic cancer
Application of ctDNA Assay in the Neoadjuvant and Adjuvant Chemotherapy Setting in Patients With Resectable Pancreatic Cancer
This study is testing if a blood test for tumor DNA can help doctors understand how well treatment is working for people with pancreatic cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Oklahoma City, Oklahoma and 1 other locations) |
| Trial ID | NCT05052671 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the presence of circulating tumor DNA (ctDNA) in the blood of patients with resectable or borderline resectable pancreatic cancer. Participants will undergo standard treatment, including chemotherapy and surgery, while their blood will be collected at various time points to assess ctDNA levels. The study seeks to determine the proportion of patients with positive ctDNA and its correlation with progression-free survival. By analyzing ctDNA, the research hopes to identify potential biomarkers that could enhance patient care and treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed resectable or borderline resectable exocrine pancreatic cancer.
Not a fit: Patients with neuroendocrine pancreatic tumors or those with locally advanced or metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and prognostic tools for patients with pancreatic cancer.
How similar studies have performed: While the use of ctDNA as a biomarker is gaining traction, this specific approach in pancreatic cancer is still being explored and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Oklahoma City, Oklahoma and 1 other locations
- University of Oklahoma — Oklahoma City, Oklahoma, United States (Recruiting)
- Stephenson Cancer Center- Tulsa — Tulsa, Oklahoma, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Sagila George — University of Oklahoma
- Study coordinator: Lead Nurse
- Email: SCC-IIT-office@ouhsc.edu
- Phone: 1-405-271-8777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.