Confirmatory Clinical Validation of a Serum-Based Biomarker Signature for Detection of Early-Stage Pancreatic Ductal Adenocarcinoma.

ABSTRACT: Early detection of pancreatic ductal adenocarcinoma (PDAC) could extend patient survival, and biomarkers to facilitate this are urgently needed. Here, we performed a second independent validation of PancreaSure, a 5-plex serum biomarker signature to detect early-stage PDAC in high-risk individuals. In contrast to the first validation, this study's cohort was preemptively balanced for age and sex and only included samples stored for fewer than 5 years. The primary endpoint was to measure test sensitivity against the performance target of 65%. Measuring specificity against the performance target of 90% and comparing test performance to that of carbohydrate antigen 19-9 (CA 19-9) alone were secondary endpoints. Signature analytes were retrospectively measured in serum from a blinded independe

SUBMITTER: Polanco PM 

PROVIDER: S-EPMC12651218 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature