RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Retrospective/Prospective Study of an Artificial Intelligence Derived Histological Biomarker to Select Neoadjuvant Treatment for Patients With Borderline Resectable or Resectable Pancreatic Ductal Adenocarcinoma

Quick Facts

Study Start:2024-01-02
Study Completion:2026-07-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06320717

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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 \[35\].
  2. * Availability of archival tumor tissue (diagnostic for PDAC) required
  3. * Have a documented ECOG Performance Status of ≤ 1
  4. * 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.
  1. * Has received prior systemic treatment (standard of care or experimental) for PDAC
  2. * Participant has a concurrent malignancy requiring active treatment during the study.

Contacts and Locations

Study Contact

Christos Fountzilas, MD
CONTACT
716-845-2300
Christos.Fountzilas@roswellpark.org

Principal Investigator

Christos Fountilas, MD
PRINCIPAL_INVESTIGATOR
Roswell Park Comprehensive Cancer Center

Study Locations (Sites)

Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
United States
Good Samaritan University Hospital
West Islip, New York, 11795
United States

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

  • Christos Fountilas, MD, PRINCIPAL_INVESTIGATOR, Roswell Park Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-02
Study Completion Date2026-07-02

Study Record Updates

Study Start Date2024-01-02
Study Completion Date2026-07-02

Terms related to this study

Additional Relevant MeSH Terms

  • Pancreatic Ductal Adenocarcinoma