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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

RecruitingObservational study

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

Who can join

All ages · All sexes

Full eligibility criteria
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).

About the 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.

What is being tested

Sponsor: Mayo Clinic · Participants: 212 · Started: Dec 4, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06689956

Locations in the U.S.

MinnesotaMayo Clinic in Rochester, Rochester
New YorkMemorial Sloan Kettering Cancer Center, New York
TexasHouston Methodist Hospital, Houston

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.