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

Pancreatic Ductal Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06320717
• Other study ID #: I-3574823
• Status: Recruiting
• Start date: January 2, 2024
• Est. completion date: July 2, 2026

Study information

• Verified date: May 2024
• Source: Roswell Park Cancer Institute
• Contact: Christos Fountzilas, MD
• Phone: 716-845-2300
• Email: Christos.Fountzilas[@]roswellpark.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2, 2026
• Est. primary completion date: July 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Intervention

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

Locations

Country	Name	City	State
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York
United States	Good Samaritan University Hospital	West Islip	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Survival status	Medical chart will be reviewed for survival status	Up to 2 years
Secondary	RECIST 1.1 response	Tumor response was determined by RECIST1.1	UP to 2 years