AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample.
- Who it may be relevant to
- Registry conditions: Pancreatic Ductal Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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
Primary outcome measures
- Retrospective prediction of pCR in resectable patients [Time frame: Up to 2 years]
- Retrospective prediction of pCR in borderline resectable patients [Time frame: Up to 2 years]
Secondary outcome measures (2)
- Survival status [Time frame: Up to 2 years]
- RECIST 1.1 response [Time frame: UP to 2 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Roswell Park Comprehensive Cancer Center — Buffalo
- Good Samaritan University Hospital — West Islip
Identifiers
NCT: NCT06320717 · I-3574823