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NCT06320717 | RECRUITING | Pancreatic Ductal Adenocarcinoma

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

Condition or disease

Pancreatic Ductal Adenocarcinoma

Intervention/treatment

Blood sample

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
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
Actual Study Start Date : 2024-01-02
Estimated Primary Completion Date : 2026-07-02
Estimated Study Completion Date : 2026-07-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma

Location Details

NCT06320717

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States, 14263

RECRUITING

United States, New York

Good Samaritan University Hospital

West Islip, New York, United States, 11795