Clinical trial · Interventional
OSNA Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer
One Step Nucleic Acid Amplification (OSNA) Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer: a Randomized, Multicenter, Controlled Trial (SENT-OSNA Study)
NCT06935305CI-TRIAL-00097417SENT-OSNArecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients enrolled in the study will be randomized before surgery: in one study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard), while in the other arm it will be conducted using the OSNA method.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OSNA | Device | — | UNRESOLVED |
| Ultrastaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ultrastaging arm
- description
- In this study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard)
- interventionNames
- Device: Ultrastaging
- type
- EXPERIMENTAL
- label
- OSNA arm
- description
- In this arm the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the OSNA method (experimental)
- interventionNames
- Device: OSNA
Primary outcomes (1)
- measure
- Number of SLN metastasis detected by OSNA versus ultrastaging method
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed endometrial cancer * Apparent (pre-operative) FIGO stage I-II * Radical surgery * Attempt of SLN mapping Exclusion Criteria: * Uterine sarcoma (including endometrial stromal sarcoma) * Fertility sparing surgery * Dedifferentiated histology * Undifferentiated histology * Neoadjuvant therapy * Previous surgery to pelvic lymph nodes * Lymph nodes with short axis \>15 mm at pre-operative imaging
References
Publications (9)
- BACKGROUNDMarchocki Z, Cusimano MC, Clarfield L, Kim SR, Fazelzad R, Espin-Garcia O, Bouchard-Fortier G, Rossi EC, Stewart KI, Soliman PT, How JA, Gotlieb WH, Holloway RW, Ianieri MM, Cabrera S, Lim YK, Ferguson SE. Sentinel lymph node biopsy in high-grade endometrial cancer: a systematic review and meta-analysis of performance characteristics. Am J Obstet Gynecol. 2021 Oct;225(4):367.e1-367.e39. doi: 10.1016/j.ajog.2021.05.034. Epub 2021 May 29. PMID 34058168
- BACKGROUNDPersson J, Salehi S, Bollino M, Lonnerfors C, Falconer H, Geppert B. Pelvic Sentinel lymph node detection in High-Risk Endometrial Cancer (SHREC-trial)-the final step towards a paradigm shift in surgical staging. Eur J Cancer. 2019 Jul;116:77-85. doi: 10.1016/j.ejca.2019.04.025. Epub 2019 Jun 7. PMID 31181536
- BACKGROUNDKoh WJ, Abu-Rustum NR, Bean S, Bradley K, Campos SM, Cho KR, Chon HS, Chu C, Cohn D, Crispens MA, Damast S, Dorigo O, Eifel PJ, Fisher CM, Frederick P, Gaffney DK, George S, Han E, Higgins S, Huh WK, Lurain JR 3rd, Mariani A, Mutch D, Nagel C, Nekhlyudov L, Fader AN, Remmenga SW, Reynolds RK, Tillmanns T, Ueda S, Wyse E, Yashar CM, McMillian NR, Scavone JL. Uterine Neoplasms, Version 1.2018, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2018 Feb;16(2):170-199. doi: 10.6004/jnccn.2018.0006. PMID 29439178
- BACKGROUNDBodurtha Smith AJ, Fader AN, Tanner EJ. Sentinel lymph node assessment in endometrial cancer: a systematic review and meta-analysis. Am J Obstet Gynecol. 2017 May;216(5):459-476.e10. doi: 10.1016/j.ajog.2016.11.1033. Epub 2016 Nov 18. PMID 27871836
- BACKGROUNDBogani G, Murgia F, Ditto A, Raspagliesi F. Sentinel node mapping vs. lymphadenectomy in endometrial cancer: A systematic review and meta-analysis. Gynecol Oncol. 2019 Jun;153(3):676-683. doi: 10.1016/j.ygyno.2019.03.254. Epub 2019 Apr 2. PMID 30952370
- BACKGROUNDConcin N, Matias-Guiu X, Vergote I, Cibula D, Mirza MR, Marnitz S, Ledermann J, Bosse T, Chargari C, Fagotti A, Fotopoulou C, Gonzalez Martin A, Lax S, Lorusso D, Marth C, Morice P, Nout RA, O'Donnell D, Querleu D, Raspollini MR, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Colombo N, Planchamp F, Creutzberg CL. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma. Int J Gynecol Cancer. 2021 Jan;31(1):12-39. doi: 10.1136/ijgc-2020-002230. Epub 2020 Dec 18.