AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoswell Park Cancer Institute

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Has received prior systemic treatment (standard of care or experimental) for PDAC

Participant has a concurrent malignancy requiring active treatment during the study.

Trial design

Treatments tested in this trial

  • Blood sample

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators