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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

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Mayo Clinic

Status

Enrolling

Conditions

Stage IA2 Endometrial Cancer FIGO 2023
FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
Stage IA1 Endometrial Cancer FIGO 2023

Treatments

Other: Non-Interventional Study

Study type

Observational

Funder types

Other

Identifiers

NCT06689956
23-008963 (Other Identifier)
NCI-2024-09016 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

212 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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).

Trial design

212 participants in 1 patient group

Observational
Description:
Patients undergo tissue sample collection and have their medical records reviewed on study.
Treatment:
Other: Non-Interventional Study

Trial contacts and locations

20

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Central trial contact

Clinical Trials Referral Office

Data sourced from clinicaltrials.gov

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