ArticleScientific reports2026
Pilot validation of a whole-blood mRNA expression-based diagnostic system for early-stage pancreatic ductal adenocarcinoma: a single-center case-control diagnostic accuracy study.
Article in Scientific reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Pancreatic ductal adenocarcinoma (PDAC) has a poor prognosis because most cases are diagnosed at an advanced stage. We previously developed a whole-blood messenger RNA (mRNA) expression-based diagnostic system using 56 genes, but its performance in very early-stage PDAC remains unclear. This single-center prospective pilot study evaluated the diagnostic accuracy of the mRNA-based system in patients with stage 0-I PDAC. Among 253 patients diagnosed between 2020 and 2024, ten with stage 0 or I disease were included. One hundred and four healthy controls were analyzed for comparison. Whole blood samples were analyzed by reverse transcription polymerase chain reaction, and a pre-specified locked algorithm generated an mRNA diagnostic score. Serum carbohydrate antigen 19 - 9 (CA19-9) was evaluated using a cut-off of 37 U/mL. The mRNA-based system detected 9 of 10 early-stage PDAC cases (sensitivity 90.0%; 95% CI 55.5-99.8%), whereas CA19-9 detected 1 of 10 (10.0%; 95% CI 2.5-44.5%). Specificity was 70.2% for the mRNA-based system and 97.1% for CA19-9. The area under the receiver operating characteristic curve was 0.84 and 0.66, respectively. These exploratory findings suggest that whole-blood transcriptomic signatures may improve diagnostic classification of highly selected patients with stage 0-I PDAC. Larger multicenter studies are required to confirm clinical utility.
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