Overview
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.
Description
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.
Eligibility
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).