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

Last updated: April 24, 2025
Sponsor: Roswell Park Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Adenocarcinoma

Pancreatic Cancer

Pancreatic Disorders

Treatment

Blood sample

Clinical Study ID

NCT06320717
I-3574823
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have histologically or cytologically confirmed PDAC that is borderline resectable (BR) (Cohort A) OR have histologically or cytologically confirmed PDAC that isresectable (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 anIndependent Ethics Committee/Institutional Review Board approved written informedconsent form (ICF) prior to receiving any study related procedure.

Exclusion

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

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Blood sample
Phase:
Study Start date:
January 02, 2024
Estimated Completion Date:
July 02, 2026

Connect with a study center

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • Good Samaritan University Hospital

    West Islip, New York 11795
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.