NCT06689956Recruiting
Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: A Prospective, Multicenter, Single-Arm Observational 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.
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).
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Brazil, Canada, Israel, Spain
- Sponsor
- Mayo Clinic(Other)
- Protocol no.
- 23-008963
- Conditions
- FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, Stage IA1 Endometrial Cancer FIGO 2023, Stage IA2 Endometrial Cancer FIGO 2023
- Interventions
- Other
Treatments studied
- Non-Interventional Study
Locations · 13
- Lugano, SwitzerlandOspedale Regionale di Lugano, CivicoRecruiting at this site
- Milan, ItalyFondazione IRCCS Istituto Nazionale TumoriRecruiting at this site
- Milan, ItalyEuropean Institute of OncologyRecruiting at this site
- Roma, ItalyPoliclinico Universitario Fondazione Agostino GemelliRecruiting at this site
- Vienna, AustriaMedical University of ViennaRecruiting at this site
- Rochester, United StatesMayo Clinic in RochesterRecruiting at this site
- New York, United StatesMemorial Sloan Kettering Cancer CenterRecruiting at this site
- Houston, United StatesHouston Methodist HospitalRecruiting at this site
- São Paulo, BrazilAC Camargo Cancer CenterRecruiting at this site
- Toronto, CanadaSunnybrook Health Sciences, University of TorontoRecruiting at this site
- Montreal, CanadaHopital Maisonneuve RosemontRecruiting at this site
- Las Palmas, SpainHospital Materno Infantil Las PalmasRecruiting at this site
- Madrid, SpainHospital Universitario La PazRecruiting at this site
In total, worldwide, 13 of the 20 sites listed in the registry are recruiting; the other 7 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: February 19, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
Other identifiers
- NCI-2024-09016 · other registry
- 23-008963 · other identifier
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.