AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma
A Retrospective/Prospective Study of an Artificial Intelligence Derived Histological Biomarker to Select Neoadjuvant Treatment for Patients With Borderline Resectable or Resectable Pancreatic Ductal Adenocarcinoma
Roswell Park Cancer Institute
100 participants
Jan 2, 2024
OBSERVATIONAL
Conditions
Summary
To collect samples and information from patients who will be undergoing standard of care neoadjuvant treatment with either FOLFIRINOX or Gemcitabine + Nab-paclitaxel. The information collected will be used to determine if there are any "biomarkers" in your blood or tumor tissue that, when compared to your response to the neoadjuvant treatment, could be used to choose the best treatment option for future patients with similar biomarkers.
Eligibility
Inclusion Criteria4
- Have histologically or cytologically confirmed PDAC that is borderline resectable (BR) (Cohort A) OR have histologically or cytologically confirmed PDAC that is resectable (Cohort B) using the National Comprehensive Cancer Network criteria \[35\].
- Availability of archival tumor tissue (diagnostic for PDAC) required
- Have a documented ECOG Performance Status of ≤ 1
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form (ICF) prior to receiving any study related procedure.
Exclusion Criteria2
- Has received prior systemic treatment (standard of care or experimental) for PDAC
- Participant has a concurrent malignancy requiring active treatment during the study.
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Interventions
To determine if there are any biomarkers in the blood that could be used to choose best treatment plan for future patients
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06320717