{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T22:36:26Z","timestamp":1790116586716,"version":"4.0.1"},"reference-count":42,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2025,11,13]],"date-time":"2025-11-13T00:00:00Z","timestamp":1762992000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"NIH\/NCI","award":["U01 CA200466"],"award-info":[{"award-number":["U01 CA200466"]}]},{"name":"NIH\/NCI","award":["U01 CA274514"],"award-info":[{"award-number":["U01 CA274514"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Current Oncology"],"abstract":"<jats:p>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\u2019s 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 independent cohort of Stage I and II PDAC cases and high-risk controls. A predictive signal for PDAC was generated from a predefined cutoff established in a previous model development study. PancreaSure distinguished early-stage PDAC from controls with 76.5% sensitivity (95% CI, 67.7\u201383.9), significantly higher than the performance target (p = 0.005). PancreaSure achieved 87.8% specificity (95% CI, 83.9\u201391.4), similar to the performance goal, and significantly outperformed sensitivity of CA 19-9 alone (p = 0.02). These results confirm that PancreaSure performs well at detecting early-stage PDAC in high-risk individuals.<\/jats:p>","DOI":"10.3390\/curroncol32110638","type":"journal-article","created":{"date-parts":[[2025,11,14]],"date-time":"2025-11-14T11:49:43Z","timestamp":1763120983000},"page":"638","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Confirmatory Clinical Validation of a Serum-Based Biomarker Signature for Detection of Early-Stage Pancreatic Ductal Adenocarcinoma"],"prefix":"10.3390","volume":"32","author":[{"given":"Patricio M.","family":"Polanco","sequence":"first","affiliation":[{"name":"Division of Surgical Oncology, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tamas","family":"Gonda","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology & Hepatology, New York University, New York, NY 10016, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5136-5462","authenticated-orcid":false,"given":"Erkut","family":"Borazanci","sequence":"additional","affiliation":[{"name":"Department of Oncology, HonorHealth Research Institute, Scottsdale, AZ 10510, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5796-0542","authenticated-orcid":false,"given":"Evan S.","family":"Glazer","sequence":"additional","affiliation":[{"name":"Division of Surgical Oncology, University of Tennessee Health Science Center, Memphis, TN 38163, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose G.","family":"Trevino","sequence":"additional","affiliation":[{"name":"Division of Surgical Oncology, School of Medicine and Surgeons, Virginia Commonwealth University, Richmond, VA 23298, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9249-9843","authenticated-orcid":false,"given":"George","family":"DeMuth","sequence":"additional","affiliation":[{"name":"Stat One, LLC, Morrisville, NC 27560, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6207-8108","authenticated-orcid":false,"given":"Lisa","family":"Ford","sequence":"additional","affiliation":[{"name":"Immunovia, Inc., Durham, NC 27713, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-8581-5824","authenticated-orcid":false,"given":"Thomas","family":"King","sequence":"additional","affiliation":[{"name":"Immunovia, Inc., Durham, NC 27713, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6900-0533","authenticated-orcid":false,"given":"Norma A.","family":"Palma","sequence":"additional","affiliation":[{"name":"Immunovia, Inc., Durham, NC 27713, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4136-3313","authenticated-orcid":false,"given":"Randall E.","family":"Brand","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, PA 15261, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,11,13]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"pkaa033","DOI":"10.1093\/jncics\/pkaa033","article-title":"Trends in the Incidence of Pancreatic Adenocarcinoma in All 50 United States Examined Through an Age-Period-Cohort Analysis","volume":"4","author":"Oluyomi","year":"2020","journal-title":"JNCI Cancer Spectr."},{"key":"ref_2","unstructured":"National Cancer Institute Surveillance Epidemiology, and End Results Program (2025, May 16). 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