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Role of one-step nucleic acid amplification (OSNA) to detect sentinel lymph node low-volume metastasis in early-stage cervical cancer
  1. Nicolò Bizzarri1,
  2. Luigi Pedone Anchora1,
  3. Gian Franco Zannoni2,
  4. Angela Santoro2,
  5. Michele Valente2,
  6. Frediano Inzani2,
  7. Valerio Gallotta1,
  8. Carmine Conte1,
  9. Vito Chiantera3,
  10. Francesco Fanfani1,2,
  11. Anna Fagotti1,2,
  12. Gabriella Ferrandina1,2 and
  13. Giovanni Scambia1,2
  1. 1Fondazione Policlinico Universitario A. Gemelli, IRCCS, UOC Ginecologia Oncologica, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Rome, Italy
  2. 2Università Cattolica del Sacro Cuore, Istituto di Ginecologia e Ostetricia, Roma, Italia, Rome, Italy
  3. 3Department of Gynecologic Oncology, ARNAS Civico Di Cristina Benfratelli, Università di Palermo, Palermo, Italy
  1. Correspondence to Dr Francesco Fanfani, Division of Gynecologic Oncology, Policlinico Universitario Agostino Gemelli, Roma 00168, Italy; francesco.fanfani74{at}


Introduction Growing evidence in the literature supports the accuracy of sentinel lymph node (SLN) biopsy in early-stage cervical cancer. One-step nucleic acid amplification (OSNA) is a rapid assay able to detect cytokeratin 19-mRNA in SLNs, and it can be used for intra-operative detection of low-volume metastases. The aim of this study was to evaluate the rate of low-volume metastasis in SLNs detected by OSNA in patients with early-stage cervical cancer. Secondary aims were to define the sensitivity and the negative predictive value of SLN biopsy assessed with OSNA.

Methods After IRB approval, consecutive patients who underwent surgery for International Federation of Gynecology and Obstetrics stage IA1 with lymph-vascular space involvement to IB1 between November 2017 and July 2019 and had SLN biopsy and pelvic lymphadenectomy were included. SLNs were detected with indocyanine-green cervical injection and sent intra-operatively for OSNA.

Results Eighteen patients underwent SLN assessment with OSNA and systematic pelvic lymphadenectomy in the study period. Four (22.2%) patients had unilateral and 14 (77.8%) had bilateral mapping. OSNA detected micro-metastasis in 6/18 (33.3%) patients. All micro-metastases were detected in patients with bilateral SLN mapping. The sensitivity and negative predictive value of SLN in detecting lymph node metastasis with OSNA calculated per pelvic sidewall were 85.7% and 96.1%, respectively. The false negative rate in mapped sidewalls was 14.3%.

Discussion This is the first series entirely processing SLNs for OSNA in early-stage cervical cancer. OSNA is able to intra-operatively detect low-volume metastases in SLNs. Further studies are necessary to confirm the accuracy of this technique and to assess survival implications of low-volume metastases detected by OSNA.

  • cervical cancer
  • sentinel lymph node
  • surgical oncology
  • lymphatic metastasis
  • neoplasm micrometastasis

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  • Editor's note This paper will feature in a special issue on sentinel lymph node mapping in 2020.

  • Twitter @frafanfani, @annafagottimd

  • Presented at The results of this study were accepted as a poster presentation at the ESGO Conference 2019, Athens, Greece, 2-5 November 2019.

  • Contributors All the authors approved the final version of the manuscript. NB: data curation, methodology, formal data analysis, writing original draft, conceptualization. LPA: data curation, methodology, formal data analysis. GFZ: data curation, methodology, review and editing, senior pathology author. AS: data curation, methodology. MV: data curation, methodology. FI: data curation, methodology, review and editing. VG: data curation, methodology, review and editing. CC: data curation, methodology. VC: methodology, data curation, review and editing. FF: conceptualization, methodology, review and editing, formal data analysis. AF: methodology, data curation, review and editing. GF: methodology, data curation, review and editing. GS: senior author and coordinator of the study, conceptualization, methodology, review and editing, writing original draft.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Commissioned; externally peer reviewed.

  • Data availability statement Data are available in a public, open access repository. Data are available upon reasonable request.