Plasma Cell-free DNA Fragmentomics for Early Detection and Diagnosis of Pancreatic Neuroendocrine and Solid Pancreatic Tumors

What this Trial Is About

Researchers are evaluating a new, less invasive method to detect pancreatic neuroendocrine tumors (pNETs) early and to distinguish these tumors from other solid pancreatic tumors. This study aims to improve early diagnosis because early-stage pNETs have a much better survival rate compared to advanced stages. The study will assess an integrated model using the fragmentomic profiles of plasma cell-free DNA, which carries genetic information from tumor cells, to improve sensitivity and specificity in detecting pNETs and differentiating between types of pancreatic tumors. Participants include patients with pNETs, pancreatic ductal adenocarcinoma (PDAC), solid pseudopapillary tumor (SPT) of the pancreas, and healthy volunteers. Blood samples will be collected to analyze the fragmentomic profiles of plasma cell-free DNA. The blood collection uses standardized procedures, including specific tubes and timing for plasma separation. The study will follow participants for up to 3 years to evaluate the model's accuracy and diagnostic performance. Participants will provide blood samples for genetic analysis and undergo follow-up to confirm diagnoses through histopathological methods. Researchers will measure the sensitivity, specificity, positive and negative predictive values of the model, and its accuracy in predicting tumor stage and grade. The study includes ongoing monitoring for up to 3 years from the first blood draw to assess early detection and differential diagnosis capabilities.

Plasma cfDNA Fragmentomics for Early pNET Detection and Differential Diagnosis of Solid Pancreatic Tumors