ExoLuminate Study: Observational Registry to Assess Exo-PDAC Assay for Detecting Pancreatic Adenocarcinoma in High-Risk or Suspicious Patients

What this Trial Is About

Researchers are evaluating a new blood test called the ExoVerita12 assay for early detection of pancreatic ductal adenocarcinoma (PDAC) in people at high risk or showing clinical signs suspicious for this cancer. This observational registry study aims to compare the performance of this test with current standard methods used to monitor and detect PDAC. The study is designed to include adults across the U.S. who have risk factors such as family history, genetic mutations, or pancreatic cysts, and will follow them over time for diagnosis outcomes. The ExoVerita12 assay uses an advanced technique to isolate extracellular vesicles from blood samples and applies a machine learning algorithm to identify specific protein markers linked to early-stage PDAC. Participants will be divided into different cohorts based on their risk factors or clinical history, including those with genetic mutations, family history, pancreatic cysts, pancreatitis, or early-stage PDAC suspicion. Blood samples will be collected at scheduled intervals to evaluate the test's ability to detect cancer early compared to standard surveillance. Participants will provide blood samples for the ExoVerita12 assay and may be monitored for up to 36 months or until diagnostic resolution. The study includes collection of medical history and follow-up data to assess the test's clinical performance and any shifts in cancer stage at diagnosis. The study poses minimal risk and does not involve investigational treatment. Data from this study will help understand how well this blood test works in detecting pancreatic cancer earlier in high-risk individuals.

ExoLuminate Study for Early Detection of Pancreatic Cancer