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

Roswell Park Comprehensive Cancer Center

Status

Enrolling

Conditions

Pancreatic Ductal Adenocarcinoma

Treatments

Other: Blood sample

Study type

Observational

Funder types

Other

Identifiers

NCT06320717

I-3574823

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.