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NCT Number: NCT06320717

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

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.

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Key information

Conditions

Pancreatic Ductal Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Retrospective prediction of pCR in resectable patients

    Time frame: Up to 2 years

    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

  2. Retrospective prediction of pCR in borderline resectable patients

    Time frame: Up to 2 years

    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)

Secondary outcomes

  1. Survival status

    Time frame: Up to 2 years

    Medical chart will be reviewed for survival status

  2. RECIST 1.1 response

    Time frame: UP to 2 years

    Tumor response was determined by RECIST1.1

Study contacts

Contact information is provided by the study sponsor or research team.

Christos Fountzilas, MD

CONTACT

[email protected]

716-845-2300

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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