Using AI to find biomarkers for better treatment of pancreatic cancer
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
This study is trying to find specific markers in blood and tumor samples from pancreatic cancer patients to see if they can help doctors choose the best treatments for future patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Locations | 2 sites (Buffalo, New York and 1 other locations) |
| Trial ID | NCT06320717 on ClinicalTrials.gov |
What this trial studies
This study aims to collect blood samples and tumor tissue from patients with borderline resectable pancreatic ductal adenocarcinoma who are undergoing standard neoadjuvant treatments like FOLFIRINOX or Gemcitabine combined with Nab-paclitaxel. The goal is to identify potential biomarkers that correlate with treatment responses, which could help in selecting the most effective treatment options for future patients. By analyzing these samples, researchers hope to enhance personalized treatment strategies for this challenging cancer type.
Who should consider this trial
Good fit: Ideal candidates include patients with borderline resectable pancreatic ductal adenocarcinoma who have not received prior systemic treatment.
Not a fit: Patients with concurrent malignancies requiring active treatment or those who have previously undergone systemic treatment for pancreatic cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more tailored and effective treatment options for patients with pancreatic cancer.
How similar studies have performed: While the use of biomarkers in cancer treatment is a growing field, this specific approach utilizing AI to select neoadjuvant treatments for pancreatic cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Buffalo, New York and 1 other locations
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Recruiting)
- Good Samaritan University Hospital — West Islip, New York, United States (Recruiting)
Study contacts
- Principal investigator: Christos Fountilas, MD — Roswell Park Comprehensive Cancer Center
- Study coordinator: Christos Fountzilas, MD
- Email: Christos.Fountzilas@roswellpark.org
- Phone: 716-845-2300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.