Scholarlink

Background <p>The preoperative classification of pancreatic cysts and detection of advanced neoplasia (high-grade dysplasia/pancreatic ductal adenocarcinoma [PDAC]) represents a significant diagnostic challenge. A prospective, multi-institutional study found that DNA-based testing (PancreaSeq) of pancreatic cyst fluid (PCF) improved the assessment of pancreatic cysts. Notable imitations to PancreaSeq necessitated the development of a DNA/RNA-based panel called PancreaSeq Genomic Classifier (GC). We validated PancreaSeq GC on a prospective patient cohort.</p> Patients and Methods <p>PancreaSeq GC was blindly tested on a prospective cohort of 241 patients with diagnostic follow-up. The performance of PancreaSeq GC in this cohort, which included 186 mucinous cysts (97 with advanced neoplasia), was benchmarked against traditional diagnostics and its DNA-only predecessor, PancreaSeq.</p> Results <p>PancreaSeq GC achieved 94.6% sensitivity and 96.4% specificity (area under the curve [AUC] of 0.955) for mucinous cysts. In comparison, increased fluid viscosity, elevated carcinoembryonic antigen (CEA), and PancreaSeq testing had lower sensitivities (71.4–88.2%) and lower AUC (0.824–0.941); however, PancreaSeq specificity was 100%. McNemar’s test demonstrated higher sensitivity of PancreaSeq GC versus PancreaSeq for mucinous cysts (<i>p</i> &lt; 0.001). For advanced neoplasia, PancreaSeq GC had 86.6% sensitivity and 97.9% specificity (AUC of 0.923), with McNemar’s test confirming improved sensitivity over PancreaSeq (<i>p</i> = 0.031). Worrisome features, malignant cytopathology, and high-risk stigmata had lower sensitivities (44.3–84.5%) and lower AUC (0.604–0.892), while PancreaSeq had identical specificity to PancreaSeq GC. PancreaSeq GC had high accuracy in classifying intraductal oncocytic papillary neoplasms (IOPNs), intraductal tubulopapillary neoplasms (ITPNs), and cystic pancreatic neuroendocrine tumors (cPanNETs), with 97.1–100% sensitivity and 100% specificity.</p> Conclusions <p>This validation study demonstrates statistically significant improvements in PancreaSeq GC for mucinous cysts and advanced neoplasia, establishing it as a clinically valuable tool for the preoperative evaluation of pancreatic cysts.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

PancreaSeq Genomic Classifier (PancreaSeq GC) Improves Pancreatic Cyst Classification and Detection of Advanced Neoplasia: A Multi-institutional Validation Study

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年12月12日

查看全文
  • Aatur D. Singhi,
  • Abigail I. Wald,
  • Katelyn Smith,
  • Lynn Wolkenstein,
  • Robert D. Bubar,
  • Ricardo Diaz-Aragon,
  • Maria Grupillo,
  • Danielle Guckin,
  • Yi-Tak Lai,
  • Randall E. Brand,
  • Kevin McGrath,
  • Walter G. Park,
  • Patrick R. Pfau,
  • Patricio M. Polanco,
  • Nisa Kubiliun,
  • John DeWitt,
  • Jeffrey J. Easler,
  • Aamir Dam,
  • Shaffer R. Mok,
  • Michael B. Wallace,
  • Brian A. Boone,
  • Wallis Marsh,
  • Shyam Thakkar,
  • Kimberly J. Fairley,
  • Elham Afghani,
  • Yasser Bhat,
  • Sanjay Ramrakhiani,
  • John Nasr,
  • Nikhil R. Thiruvengadam,
  • Asif Khalid,
  • Kenneth Fasanella,
  • Jennifer Chennat,
  • Rohit Das,
  • Harkirat Singh,
  • Adam Slivka,
  • Charles Gabbert,
  • Tarek Sawas,
  • Thomas Tielleman,
  • Hendrikus Dutch Vanderveldt,
  • Anna Tavakkoli,
  • Lynette M. Smith,
  • Anju H. Singhi,
  • Sara A. Singhi,
  • Stephanie Romutis,
  • Sultan Mahmood,
  • Amy E. Hosmer,
  • Julia McNabb-Baltar,
  • Anne Marie Lennon,
  • Ralph H. Hruban,
  • Nuha Shaker,
  • Alessandro Paniccia,
  • Amer Zureikat,
  • Kenneth K. Lee,
  • Melanie Ongchin,
  • Herbert Zeh,
  • Rebecca Minter,
  • C. Max Schmidt,
  • Jin He,
  • Marina N. Nikiforova

摘要

Background

The preoperative classification of pancreatic cysts and detection of advanced neoplasia (high-grade dysplasia/pancreatic ductal adenocarcinoma [PDAC]) represents a significant diagnostic challenge. A prospective, multi-institutional study found that DNA-based testing (PancreaSeq) of pancreatic cyst fluid (PCF) improved the assessment of pancreatic cysts. Notable imitations to PancreaSeq necessitated the development of a DNA/RNA-based panel called PancreaSeq Genomic Classifier (GC). We validated PancreaSeq GC on a prospective patient cohort.

Patients and Methods

PancreaSeq GC was blindly tested on a prospective cohort of 241 patients with diagnostic follow-up. The performance of PancreaSeq GC in this cohort, which included 186 mucinous cysts (97 with advanced neoplasia), was benchmarked against traditional diagnostics and its DNA-only predecessor, PancreaSeq.

Results

PancreaSeq GC achieved 94.6% sensitivity and 96.4% specificity (area under the curve [AUC] of 0.955) for mucinous cysts. In comparison, increased fluid viscosity, elevated carcinoembryonic antigen (CEA), and PancreaSeq testing had lower sensitivities (71.4–88.2%) and lower AUC (0.824–0.941); however, PancreaSeq specificity was 100%. McNemar’s test demonstrated higher sensitivity of PancreaSeq GC versus PancreaSeq for mucinous cysts (p < 0.001). For advanced neoplasia, PancreaSeq GC had 86.6% sensitivity and 97.9% specificity (AUC of 0.923), with McNemar’s test confirming improved sensitivity over PancreaSeq (p = 0.031). Worrisome features, malignant cytopathology, and high-risk stigmata had lower sensitivities (44.3–84.5%) and lower AUC (0.604–0.892), while PancreaSeq had identical specificity to PancreaSeq GC. PancreaSeq GC had high accuracy in classifying intraductal oncocytic papillary neoplasms (IOPNs), intraductal tubulopapillary neoplasms (ITPNs), and cystic pancreatic neuroendocrine tumors (cPanNETs), with 97.1–100% sensitivity and 100% specificity.

Conclusions

This validation study demonstrates statistically significant improvements in PancreaSeq GC for mucinous cysts and advanced neoplasia, establishing it as a clinically valuable tool for the preoperative evaluation of pancreatic cysts.