7d9dc42044142a81741739970f94b525 pmc_11679750.pdf 0918a48086a36b857cbc66fa3906c56e0df2aac4 pmc_11679750.pdf 4cacea357ece3bbd1dc53e3e05b47f842ccbae87aafb8b6135ffb90c1d1b4697 pmc_11679750.pdf Title: Molecular Detection of Lymph Node Metastases with One-Step Nucleic Acid Amplification (OSNA) Pooling in Prostate Cancer: The POPCORN Study "2279 Subject: Pelvic lymph node dissection (PLND) is the most accurate procedure for lymph node (LN) staging in prostate cancer (PCa) patients. LN sectioning and hematoxylin and eosin (H&E) staining of at least one slice remains the gold standard for LN evaluation, potentially leading to misdetection of small metastatic focus. Entire LN analysis is possible with One-Step Nucleic Acid Amplification (OSNA) by detecting cytokeratin 19 (CK19) mRNA as a surrogate for LN invasion. This study aimed to compare postoperative performance of OSNA pooling with conventional H&E staining for pathological LN detection in PCa patients. POPCORN was an observational, prospective, and multicenter study of patients with PCa who underwent PLND. Dissected LNs were analyzed by both methods. This study included 2503 LNs from 131 patients, showing no statistically significant differences in pathological LN detection. Concordance between methods was high (93.9%), as were specificity (96.6%) and negative predictive value (96.6%) of OSNA pooling. The measure of agreement (Cohen’s Kappa []) was 0.70. Only eight (6.1%) discordances were observed, including four misdetections from each method. Results showed a high concordance between OSNA pooling and H&E staining, suggesting that OSNA pooling may be a good alternative to H&E staining to detect LN metastases in PCa patients. Keywords: prostate cancer; pelvic lymph node dissection; lymph node metastases; OSNA; cytokeratin 19; pooling; hematoxylin and eosin staining Author: Mercè Cuadras, Maria E. Semidey, Jacques Planas, Inés M. de Torres, Lucas Regis, Ana Celma, Enrique Trilla, Santiago Ramón y Cajal, Rafael A. Medina, Belén Congregado, David Marcilla, Miguel A. Japón, Miguel Ramirez, Ana Calatrava-Fons, Asier Leivar, María B. Alonso, Eugenia García, Pilar González-Peramato, Dario Vazquez-Martul, Ángel Concha-López, Venancio Chantada, Francisco J. Queipo, José L. Gago, Cristina Carrato, Rafael J. Luque, Juan Moreno-Jimenez, Inmaculada Catalina-Fernández, Cristina León and Juan Morote Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25 CreationDate: Tue Dec 17 06:45:25 2024 CET ModDate: Tue Dec 17 07:50:57 2024 CET Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 13 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 1527180 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- JFUQEY+VnURWPalladioL-Bold Type 1 Custom yes yes yes 10 0 DUAOLJ+URWPalladioL-Bold Type 1 Custom yes yes yes 16 0 LJPIDW+URWPalladioL-Roma Type 1 Custom yes yes yes 22 0 TBKVXA+URWPalladioL-Ital Type 1 Custom yes yes yes 27 0 LOYSUQ+VnURWPalladioL Type 1 Custom yes yes yes 32 0 AYXMDM+EURM10 Type 1 Builtin yes yes yes 62 0 WBVKDJ+URWPalladioL-BoldItal Type 1 Custom yes yes yes 74 0 RQPVQI+CMSY10 Type 1 Builtin yes yes yes 79 0 BCDEEE+PalatinoLinotype-Bold TrueType WinAnsi yes yes no 88 0 BCDFEE+PalatinoLinotype-Roman TrueType WinAnsi yes yes no 92 0 BCDGEE+PalatinoLinotype-Italic TrueType WinAnsi yes yes no 96 0 BCDHEE+PalatinoLinotype-Italic CID TrueType Identity-H yes yes yes 100 0 BCDIEE+PalatinoLinotype-Bold CID TrueType Identity-H yes yes yes 107 0 BCDJEE+PalatinoLinotype-Roman CID TrueType Identity-H yes yes yes 114 0 BCDKEE+PalatinoLinotype-BoldItalic TrueType WinAnsi yes yes no 121 0 BCDEEE+PalatinoLinotype-Bold TrueType WinAnsi yes yes no 135 0 BCDFEE+PalatinoLinotype-Roman TrueType WinAnsi yes yes no 139 0 BCDGEE+PalatinoLinotype-Italic TrueType WinAnsi yes yes no 143 0 BCDHEE+PalatinoLinotype-Italic CID TrueType Identity-H yes yes yes 147 0 BCDIEE+PalatinoLinotype-Bold CID TrueType Identity-H yes yes yes 154 0 BCDJEE+PalatinoLinotype-Roman CID TrueType Identity-H yes yes yes 161 0 BCDEEE+PalatinoLinotype-Bold TrueType WinAnsi yes yes no 192 0 BCDFEE+PalatinoLinotype-Roman TrueType WinAnsi yes yes no 196 0 BCDGEE+PalatinoLinotype-Italic TrueType WinAnsi yes yes no 200 0 BCDIEE+PalatinoLinotype-Bold CID TrueType Identity-H yes yes yes 204 0 BCDJEE+PalatinoLinotype-Roman CID TrueType Identity-H yes yes yes 211 0 XIRVNA+EURB10 Type 1 Builtin yes yes yes 223 0 BCDEEE+PalatinoLinotype-Bold TrueType WinAnsi yes yes no 242 0 BCDFEE+PalatinoLinotype-Roman TrueType WinAnsi yes yes no 246 0 BCDGEE+PalatinoLinotype-Italic TrueType WinAnsi yes yes no 250 0 BCDHEE+PalatinoLinotype-Italic CID TrueType Identity-H yes yes yes 254 0 BCDIEE+PalatinoLinotype-Bold CID TrueType Identity-H yes yes yes 261 0 BCDJEE+PalatinoLinotype-Roman CID TrueType Identity-H yes yes yes 268 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2025-02-13 02:52:22 CET RepresentationInformation: pmc_11679750.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2025-02-11 02:32:16 CET Size: 1527180 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 443 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Results Destination: section.2 Children: Item: Title: Characteristics of Study Patients Destination: subsection.2.1 Item: Title: Detection of Lymph Node Metastases per Patient with OSNA Pooling Destination: subsection.2.2 Item: Title: Discordances Between H&E Staining and OSNA Pooling Destination: subsection.2.3 Item: Title: Discussion Destination: section.3 Item: Title: Materials and Methods Destination: section.4 Children: Item: Title: Study Design and Patients Destination: subsection.4.1 Item: Title: Study Variables Destination: subsection.4.2 Item: Title: Collection and Processing of Lymph Nodes Destination: subsection.4.3 Item: Title: H&E Staining Destination: subsection.4.4 Item: Title: OSNA Pooling Analysis Destination: subsection.4.5 Item: Title: Statistical Analysis Destination: subsection.4.6 Item: Title: Conclusions Destination: section.5 Item: Title: References Destination: section.6 Info: Title: Molecular Detection of Lymph Node Metastases with One-Step Nucleic Acid Amplification (OSNA) Pooling in Prostate Cancer: The POPCORN Study "2279 Author: Mercè Cuadras, Maria E. Semidey, Jacques Planas, Inés M. de Torres, Lucas Regis, Ana Celma, Enrique Trilla, Santiago Ramón y Cajal, Rafael A. Medina, Belén Congregado, David Marcilla, Miguel A. Japón, Miguel Ramirez, Ana Calatrava-Fons, Asier Leivar, María B. Alonso, Eugenia García, Pilar González-Peramato, Dario Vazquez-Martul, Ángel Concha-López, Venancio Chantada, Francisco J. Queipo, José L. Gago, Cristina Carrato, Rafael J. Luque, Juan Moreno-Jimenez, Inmaculada Catalina-Fernández, Cristina León and Juan Morote Subject: Pelvic lymph node dissection (PLND) is the most accurate procedure for lymph node (LN) staging in prostate cancer (PCa) patients. LN sectioning and hematoxylin and eosin (H&E) staining of at least one slice remains the gold standard for LN evaluation, potentially leading to misdetection of small metastatic focus. Entire LN analysis is possible with One-Step Nucleic Acid Amplification (OSNA) by detecting cytokeratin 19 (CK19) mRNA as a surrogate for LN invasion. This study aimed to compare postoperative performance of OSNA pooling with conventional H&E staining for pathological LN detection in PCa patients. POPCORN was an observational, prospective, and multicenter study of patients with PCa who underwent PLND. Dissected LNs were analyzed by both methods. This study included 2503 LNs from 131 patients, showing no statistically significant differences in pathological LN detection. Concordance between methods was high (93.9%), as were specificity (96.6%) and negative predictive value (96.6%) of OSNA pooling. The measure of agreement (Cohen’s Kappa []) was 0.70. Only eight (6.1%) discordances were observed, including four misdetections from each method. Results showed a high concordance between OSNA pooling and H&E staining, suggesting that OSNA pooling may be a good alternative to H&E staining to detect LN metastases in PCa patients. 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