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

NCT06320717 | Recruiting DMC

• 1 other identifier: I-3574823
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Retrospective prediction of pCR in 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

  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)

  Up to 2 years

Secondary Outcomes (2)

• Survival status

  Up to 2 years

• RECIST 1.1 response

  UP to 2 years

Study Arms (2)

Patients with Borderline Resectable (Cohort A)

Pathological response of Patients with borderline resectable disease (per NCCD Criteria) treated with standard care chemotherapy

Other: Blood sample

Patients with Resectable (Cohort B)

Pathological response of Patients with resectable disease (per NCCN criteria) treated with standard care chemotherapy

Other: Blood sample

Interventions

Blood sample OTHER

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

Patients with Borderline Resectable (Cohort A); Patients with Resectable (Cohort B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community practices and hospital clinics

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (2)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

RECRUITING

Good Samaritan University Hospital

West Islip, New York, 11795, United States

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christos Fountilas, MD

  Roswell Park Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christos Fountzilas, MD

CONTACT

716-845-2300; Christos.Fountzilas@roswellpark.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: January 2, 2024
• Primary Completion (Estimated): July 2, 2026
• Study Completion (Estimated): July 2, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (2)