OSNA Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer

NCT06935305 | Recruiting

• 1 other identifier: 7170
• Study Type: interventional
• Target: 1,922
• Locations: 1 country
• Sites: 1

Brief Summary

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

Endometrial Cancer

Keywords

endometrial cancer; OSNA; sentinel lymph node; ultrastaging

Outcome Measures

Primary Outcomes (1)

• Number of SLN metastasis detected by OSNA versus ultrastaging method

  We will evaluate the number of lymph node metastases identified with both methods, in order to calculate the incidence of lymph node metastases for each group

  From enrollment to the acquisition of the histological examination (8 weeks)

Secondary Outcomes (9)

• Overall survival (measured in months) in patients with a diagnosis of lymph node metastases (identified with OSNA and ultrastaging), performing stratification by molecular class.

  3 years (a 3-year follow-up is planned)

• Disease-free survival (measured in months) in patients with a diagnosis of lymph node metastases (identified with OSNA and ultrastaging), performing stratification by molecular class.

  3 years (a 3-year follow-up is planned)

• 3 year disease-free survival (measured in months) in OSNA versus ultrastaging negative patients

  3 years (a 3-year follow-up is planned)

• 3 year overall survival (measured in months) in OSNA versus ultrastaging negative patients

  3 years (a 3-year follow-up is planned)

• 5-year disease-free survival (measured in months) in OSNA versus ultrastaging negative patients

  5 years

Study Arms (2)

ultrastaging arm

ACTIVE COMPARATOR

In this study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard)

Device: Ultrastaging

OSNA arm

EXPERIMENTAL

In this arm the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the OSNA method (experimental)

Device: OSNA

Interventions

OSNA DEVICE

The search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the OSNA method

OSNA arm

Ultrastaging DEVICE

The search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method

ultrastaging arm

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed endometrial cancer
• Apparent (pre-operative) FIGO stage I-II
• Radical surgery
• Attempt of SLN mapping

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Sysmex Europe GmbH: collaborator

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy, 00168, Italy

RECRUITING

Related Publications (8)

• Marchocki 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 BACKGROUND

• Persson 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 BACKGROUND

• Koh 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 BACKGROUND

• Bodurtha 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 BACKGROUND

• Bogani 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 BACKGROUND

• Concin 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.

  PMID: 33397713 BACKGROUND

• Lortet-Tieulent J, Ferlay J, Bray F, Jemal A. International Patterns and Trends in Endometrial Cancer Incidence, 1978-2013. J Natl Cancer Inst. 2018 Apr 1;110(4):354-361. doi: 10.1093/jnci/djx214.

  PMID: 29045681 BACKGROUND

• Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.

  PMID: 33433946 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Francesco Fanfani, Professor

  Fondazione Policlinico Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Fanfani, Professor

CONTACT

+390630153421; francesco.fanfani@policlinicogemelli.it

Nicolò Bizzarri, Dr

CONTACT

+393471771680; nicolo.bizzarri@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Francesco Fanfani

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: April 20, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): September 17, 2026
• Study Completion (Estimated): March 17, 2029
• Last Updated: November 18, 2025

Record last verified: 2024-12

Locations

IT (1)