Pancreatic Ductal Adenocarcinoma
Conditions
Brief 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.
Interventions
OTHERBlood sample
To determine if there are any biomarkers in the blood that could be used to choose best treatment plan for future patients
Sponsors
Roswell Park Cancer Institute
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retrospective prediction of pCR in resectable patients | Up to 2 years | 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 |
| Retrospective prediction of pCR in borderline resectable patients | Up to 2 years | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival status | Up to 2 years | Medical chart will be reviewed for survival status |
| RECIST 1.1 response | UP to 2 years | Tumor response was determined by RECIST1.1 |
Countries
United States
Contacts
CONTACTChristos Fountzilas, MD
PRINCIPAL_INVESTIGATORChristos Fountilas, MD
Roswell Park Comprehensive Cancer Center
Outcome results
None listed