OSNA Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Apr 16, 2025
Trial Information
Current as of May 24, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two different methods for detecting cancer spread in sentinel lymph nodes for women with endometrial cancer, which is cancer of the lining of the uterus. The study will compare a standard method called ultrastaging with a newer technique known as OSNA. The goal is to find out which method is better at detecting any cancer that may have spread to these lymph nodes, which are small glands that help fight infection and can also be affected by cancer.
To be eligible for this trial, participants must be women who have been diagnosed with endometrial cancer that is at an early stage (stage I or II) and are planning to have surgery. They should not have certain types of uterine cancers or previous treatments that could affect the study's results. If you join this trial, you will be randomly assigned to one of the two methods during your surgery. The study is not recruiting participants just yet, but it aims to help improve how doctors detect cancer in women undergoing surgery for endometrial cancer.
Gender
FEMALE
Eligibility criteria
- 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
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rome, , Italy
Patients applied
Trial Officials
Francesco Fanfani, Professor
Principal Investigator
Fondazione Policlinico Agostino Gemelli IRCCS
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported