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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• Mayo Clinic in Rochester, Rochester, Minnesota, United States
• Memorial Sloan Kettering Cancer Center, New York, New York, United States
• Houston Methodist Hospital, Houston, Texas, United States
• Medical University of Vienna, Vienna, Austria
• AC Camargo Cancer Center, São Paulo, Brazil
• Sunnybrook Health Sciences, University of Toronto, Toronto, Ontario, Canada
• Hopital Maisonneuve Rosemont, Montreal, Quebec, Canada
• 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

+ 8 more sites.

Who to contact

Clinical Trials Referral Office · 855-776-0015 · mayocliniccancerstudies@mayo.edu

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06689956.