Ireland
--:--IST
Recruiting Observational

Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: A Prospective, Multicenter, Single-Arm Observational Study

NCT06689956 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-12-04
Last updated
2026-02-19

Condition(s) studied

FIGO Grade 1 Endometrial Endometrioid AdenocarcinomaFIGO Grade 2 Endometrial Endometrioid AdenocarcinomaStage IA1 Endometrial Cancer FIGO 2023Stage IA2 Endometrial Cancer FIGO 2023

Investigational drug(s) / intervention(s)

Non-Interventional Study

Non-Interventional Study: Non-Interventional Study

Study summary

This study evaluates whether isolated tumor cells in the first lymph nodes near the tumor can tell researchers something important about the future of patients with a certain type of endometrial (uterine) cancer.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Low-risk endometrial cancer, defined as endometrioid, grade 1 or 2, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA (FIGO 2023 stages IA1 and IA2), without substantial/extensive LVSI (≥ 5 vessels involved) at final pathology. Patients with focal LVSI (\< 5 vessels involved) will be included. * Complete surgical staging, including pelvic sentinel lymph node (SLN) biopsy per National Comprehensive Cancer Network (NCCN) guidelines and ultrastaging. * Extent of disease in SLN: ITC (defined as tumor cell aggregates ≤ 0.2 mm or \< 200 cells) * No adjuvant treatment after surgery * Research consent provided. Exclusion Criteria: * Prior neoadjuvant chemotherapy. * Planning to receive adjuvant treatment. * Presence of synchronous cancer (excluding non-melanoma skin cancer). * Extent of disease in SLN: micrometastasis (\> 0.2 to ≤ 2.0 mm) or macrometastasis (\> 2.0 mm). * Presence of substantial/extensive LVSI (≥ 5 vessels involved) at final pathology. * Prior invasive cancer diagnosis within 5 years of study entry (excluding non-melanoma skin cancer).

Primary outcome measure(s)

  • Recurrence-free survival (RFS) — Up to 5 years
    RFS is defined as the length of time after primary treatment that the patient survives without any signs or symptoms of that cancer. (Recurrence may be vaginal, hematogenous, lymphatic, or peritoneal.) RFS will be measured from the date of surgery to the date of recurrence, death, or last disease evaluation.

Trial sites (20)

FacilityCityRegionStatus
Mayo Clinic in Rochester Rochester Minnesota Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Houston Methodist Hospital Houston Texas Recruiting
Medical University of Vienna Vienna Austria Recruiting
AC Camargo Cancer Center São Paulo Brazil Recruiting
Sunnybrook Health Sciences, University of Toronto Toronto Ontario Recruiting
Hopital Maisonneuve Rosemont Montreal Quebec Recruiting
Institut Universitaire du Cancer Toulouse Oncopole Toulouse France Not Yet Recruiting
University Hospital Essen Essen Germany Not Yet Recruiting
Meir Medical Center, Faculty of Medicine - Tel-Aviv University Kefar Sava Israel Not Yet Recruiting
Ospedale Michele e Pietro Ferrero Verduno CN Not Yet Recruiting
IRCCS Fondazione San Gerardo dei Tintori Monza MB Not Yet Recruiting
Fondazione IRCCS Istituto Nazionale Tumori Milan MI Recruiting
European Institute of Oncology Milan MI Recruiting
Policlinico Universitario Fondazione Agostino Gemelli Roma RM Recruiting
University of Udine Udine UD Not Yet Recruiting
Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale Naples Italy Not Yet Recruiting
Hospital Materno Infantil Las Palmas Las Palmas Spain Recruiting
Hospital Universitario La Paz Madrid Spain Recruiting
Ospedale Regionale di Lugano, Civico Lugano Switzerland Recruiting

More Mayo Clinic trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06689956 on ClinicalTrials.gov ↗ ← All trials in Italy