Actively Recruiting
AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable or Resectable Pancreatic Ductal Adenocarcinoma
Led by Roswell Park Cancer Institute · Updated on 2026-04-30
100
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting samples and information from patients diagnosed with pancreatic ductal adenocarcinoma (PDAC) who will receive standard neoadjuvant chemotherapy with either FOLFIRINOX or Gemcitabine plus Nab-paclitaxel. The study aims to find blood or tumor biomarkers that could help predict how patients respond to these treatments and guide future therapy choices. This observational research focuses on patients with borderline resectable or resectable PDAC according to National Comprehensive Cancer Network criteria. Participants will undergo standard care chemotherapy and provide blood samples and archival tumor tissue for biomarker analysis. The study follows two groups: patients with borderline resectable disease and those with resectable disease. Researchers will compare the pathological response to treatment in these groups and assess biomarkers retrospectively to evaluate their potential to predict complete pathological response. During the study, patients' survival status and tumor response will be monitored for up to two years. Researchers will collect and analyze data including blood samples, tumor tissue, and clinical outcomes using RECIST 1.1 criteria. The study involves informed consent and requires participants to have good performance status. This observational study does not involve experimental treatment but focuses on gathering data to improve future treatment selection.
CONDITIONS
Brief Title
AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have histologically or cytologically confirmed pancreatic ductal adenocarcinoma that is borderline resectable or resectable according to National Comprehensive Cancer Network criteria
- Availability of archival tumor tissue diagnostic for pancreatic ductal adenocarcinoma
- Have a documented ECOG Performance Status of 1 or less
- Understand the investigational nature of this study and sign an approved informed consent form before any study procedures
You will not qualify if you...
- Have received prior systemic treatment (standard or experimental) for pancreatic ductal adenocarcinoma
- Have a concurrent malignancy requiring active treatment during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants provide blood samples to identify biomarkers that may help select the best treatment plans for future patients.
1 to 2 visits depending on cohort assignment
Duration - Up to 2 years
Participants are observed for survival status and treatment responses over time.
Periodic assessments depending on clinical follow-up
Trial Site Locations
Total: 2 locations
1
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
2
Good Samaritan University Hospital
West Islip, New York, United States, 11795
Actively Recruiting
Research Team
C
Christos Fountzilas, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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