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

Recruiting

• Conditions: Pancreatic Ductal Adenocarcinoma
• Interventions: Other: Blood sample

• Registration Number: NCT06320717
• Lead Sponsor: Roswell Park Cancer Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-02
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25
• Primary Completion: 2026-07-02
• Study Completion: 2026-07-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Resectable (Cohort B)	Blood sample	Pathological response of Patients with resectable disease (per NCCN criteria) treated with standard care chemotherapy
Patients with Borderline Resectable (Cohort A)	Blood sample	Pathological response of Patients with borderline resectable disease (per NCCD Criteria) treated with standard care chemotherapy

Primary Outcome Measures

Name	Time	Method
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)
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Good Samaritan University Hospital; 🇺🇸 West Islip, New York, United States

Roswell Park Comprehensive Cancer Center; 🇺🇸 Buffalo, New York, United States