BACKGROUND: This is a multicentre, European, prospective trial evaluating the diagnostic accuracy of One Step Nucleic Acid Amplification (OSNA) compared to sentinel lymph nodes histopathological ultrastaging in endometrial cancer patients. METHODS: Centres with expertise in sentinel lymph node mapping in endometrial cancer patients in Europe will be invited to participate in the study. Participating units will be trained on the correct usage of the OSNA RD-210 analyser and nucleic acid amplification reagent kit LYNOAMP CK19 E for rapid detection of metastatic nodal involvement, based on the cytokeratin 19 (CK19) mRNA detection. Endometrial cancer patients ≥ 18 years listed for surgical treatment with sentinel lymph node mapping, with no history of other types of cancer and who provide a valid written consent will be considered potentially eligible for the study. However, they will only be enrolled if a successful sentinel lymph node mapping is retrieved. Each node will be processed according to the study protocol and assessed by both OSNA and ultrastaging. DISCUSSION: The accuracy of OSNA (index test) will be assessed against sentinel lymph node histopathological ultrastaging (reference test). This European study has the potential to be the largest study on the use of OSNA in endometrial cancer to date. OSNA could represent a modern diagnostic alternative to sentinel lymph node ultrastaging with the added benefits of standardisation and fast results. TRIAL REGISTRATION: The study was registered in the German Clinical Trial Register - Nr. DRKS00021520, registration date 25th of May 2020, URL of the trial registry record: https://drks.de/search/en/trial/DRKS00021520 .

• Klíčová slova
• Endometrial cancer, OSNA, Sentinel lymph nodes, Ultrastaging,
• MeSH
• biopsie sentinelové lymfatické uzliny metody   MeSH
• keratin-19 genetika   MeSH
• lidé MeSH
• lymfatické metastázy * diagnóza   patologie   MeSH
• lymfatické uzliny patologie   MeSH
• multicentrické studie jako téma MeSH
• nádory endometria * patologie   genetika   diagnóza   MeSH
• prospektivní studie MeSH
• sentinelová uzlina * patologie   MeSH
• staging nádorů MeSH
• techniky amplifikace nukleových kyselin * metody   MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• protokol klinické studie MeSH
• Geografické názvy
• Evropa MeSH
• Názvy látek
• keratin-19 MeSH

AIMS: Endometrial cancer (EC) is the most common gynecological cancer worldwide and its incidence is rising. The cornerstone of its management is surgical treatment with nodal staging. A monocentric study investigating the potential of the molecular biology method of one-step nucleic acid amplification (OSNA) in sentinel lymph node (SLN) analysis was conducted at our institution between April 2016 and January 2018. Histopathological ultrastaging was used as the reference standard for SLN examination and OSNA as the index test. The aim of this study was to assess the long-term outcome of patients with discordant SLN and OSNA results. To our knowledge, this is the first study exploring this issue. METHODS AND RESULTS: Patients were followed in line with the current ESMO/ESGO/ESTRO recommendations. The institutional electronic database was retrospectively searched for patients' follow-up data from April 2016 till March 2023. Only patients who provided a written valid consent and had a positive OSNA and negative ultrastaging of their SLN analysis were included in the study. The primary endpoint was the retrospective analysis of their clinical outcome. Data from 58 patients enrolled into our previous study were reviewed and 12 discordant patients who met the inclusion criteria for this study were identified. The median follow-up was 83 months. Disease recurrence was detected in 3 (25%) patients, two of these were nodal and both patients died. One patient had a solitary lung metastasis which was surgically treated, and the patient was disease-free during the whole study period. CONCLUSION: The recurrence rate of patients included in the study was in the intermediate-high and high-risk group range, and hence, higher than expected based on ultrastaging results. Furthermore, benign epithelial inclusions do not seem to adversely affect OSNA SLN analysis in EC patients.

• Klíčová slova
• OSNA, endometrial cancer, follow‐up, sentinel node,
• MeSH
• biopsie sentinelové lymfatické uzliny * MeSH
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• lokální recidiva nádoru patologie   genetika   epidemiologie   MeSH
• lymfatické metastázy patologie   diagnóza   MeSH
• nádory endometria * genetika   patologie   chirurgie   MeSH
• následné studie MeSH
• retrospektivní studie MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• sentinelová uzlina * patologie   chirurgie   MeSH
• staging nádorů * MeSH
• techniky amplifikace nukleových kyselin * metody   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• srovnávací studie MeSH