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

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

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.

PRIMARY OBJECTIVE:

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.

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).