Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective Multicenter Single-Arm Observational Study
Mayo Clinic
Summary
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
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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) *…
Interventions
- OtherNon-Interventional Study
Non-Interventional Study
Locations (20)
- Mayo Clinic in RochesterRochester, Minnesota
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Houston Methodist HospitalHouston, Texas
- Medical University of ViennaVienna
- AC Camargo Cancer CenterSão Paulo
- Sunnybrook Health Sciences, University of TorontoToronto, Ontario