RecruitingNCT06689956
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
Sponsor
Mayo Clinic
Enrollment
212 participants
Start Date
Dec 4, 2024
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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).
Interventions
OTHERNon-Interventional Study
Non-Interventional Study
Locations(20)
View Full Details on ClinicalTrials.gov
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NCT06689956