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

Recruitingn/aAges any - anyAllMayo Clinic
NCT06689956 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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).
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What it tests

  • Non-Interventional Study
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Where

20 sites
Mayo Clinic in Rochester
Rochester, United States
Memorial Sloan Kettering Cancer Center
New York, United States
Houston Methodist Hospital
Houston, United States
Medical University of Vienna
Vienna, Austria
AC Camargo Cancer Center
São Paulo, Brazil
Sunnybrook Health Sciences, University of Toronto
Toronto, Canada
Hopital Maisonneuve Rosemont
Montreal, Canada
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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