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

N/ARecruitingNCT06320717

Roswell Park Cancer Institute100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Pancreatic Ductal Adenocarcinoma

Interventions

Blood sampleOTHER

To determine if there are any biomarkers in the blood that could be used to choose best treatment plan for future patients

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * Has received prior systemic treatment (standard of care or experimental) for PDAC * Participant has a concurrent malignancy requiring active treatment during the study.

Outcomes

Primary Outcomes

Retrospective prediction of pCR in resectable patients

Time frame: Up to 2 years

Retrospective prediction of pCR in borderline resectable patients

Pathologic response is based on the American College of Pathology Criteria. The AI classified treatment is based on the best representative slide analyzed by the Valar Labs AI algorithm for V-FFX (is Folfirinox recommended) and V-GNP (is GEM/NAB-Paclitaxel recommended). Pathologic response is based on the American College of Pathology Criteria. The AI classified treatment is based on the best representative slide analyzed by the Valar Labs AI algorithm for V-FFX (is Folfirinox recommended) and V-GNP (is GEM/NAB-Paclitaxel recommended)

Time frame: Up to 2 years

Secondary Outcomes

Survival status

Medical chart will be reviewed for survival status

Time frame: Up to 2 years

RECIST 1.1 response

Tumor response was determined by RECIST1.1

Time frame: UP to 2 years

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts