Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: A Prospective, Multicenter, Single-Arm Observational Study
Recruiting now
Conditions studied: FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, Stage IA1 Endometrial Cancer FIGO 2023, Stage IA2 Endometrial Cancer FIGO 2023
In brief
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.
Key facts
- Study ID
- NCT06689956
- Run by
- Mayo Clinic
- People needed
- 212
- Starts
- 2024-12-04
- Expected to finish
- 2029-10-31
- Last updated by the study team
- 2026-02-19
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- Houston Methodist Hospital — Houston, Texas, United States (enrolling)
- Medical University of Vienna — Vienna, Austria (enrolling)
- AC Camargo Cancer Center — São Paulo, Brazil (enrolling)
- Sunnybrook Health Sciences, University of Toronto — Toronto, Ontario, Canada (enrolling)
- Hopital Maisonneuve Rosemont — Montreal, Quebec, Canada (enrolling)
- Fondazione IRCCS Istituto Nazionale Tumori — Milan, MI, Italy (enrolling)
- European Institute of Oncology — Milan, MI, Italy (enrolling)
- Policlinico Universitario Fondazione Agostino Gemelli — Roma, RM, Italy (enrolling)
- Hospital Materno Infantil Las Palmas — Las Palmas, Spain (enrolling)
- Hospital Universitario La Paz — Madrid, Spain (enrolling)
- Ospedale Regionale di Lugano, Civico — Lugano, Switzerland (enrolling)
- University of Udine — Udine, UD, Italy
- Institut Universitaire du Cancer Toulouse Oncopole — Toulouse, France
- University Hospital Essen — Essen, Germany
- Meir Medical Center, Faculty of Medicine - Tel-Aviv University — Kefar Sava, Israel
- Ospedale Michele e Pietro Ferrero — Verduno, CN, Italy
- IRCCS Fondazione San Gerardo dei Tintori — Monza, MB, Italy
- Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale — Naples, Italy
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.