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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
Trial Status: active
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 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).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06689956.
I. To evaluate whether the likelihood of disease recurrence differs between a prospective cohort of patients with low-risk endometrial cancer with ITC and an historical cohort with negative SLNs.
OUTLINE: This is an observational study.
Patients undergo tissue sample collection and have their medical records reviewed on study.
