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Observational Study for Low-Risk Endometrial Cancer

This study is looking at women with low-risk endometrial cancer (a type of uterine cancer) that has isolated tumor cells in the sentinel lymph nodes (the first lymph nodes where cancer cells are likely to spread). Researchers want to see if having these cells affects how likely the cancer is to come back. You may be able to join if you have endometrioid endometrial cancer, Grade 1 or 2, Stage IA (FIGO 2009) or Stage IA1/IA2 (FIGO 2023), with limited or no substantial LVSI (lymphovascular space invasion, meaning cancer cells in blood or lymph vessels). The main goal is to compare recurrence-free survival (how long you live without the cancer returning) in this group to historical data. This is an observational study, meaning you will not receive a new treatment as part of the study.

Study design
This is a single-arm observational study planning to enroll 212 participants. It is not a randomized trial.
What's involved
You will have tissue samples collected and your medical records reviewed as part of this study.
Compensation
Not stated in the trial record.
Follow-up
Your recurrence-free survival will be measured for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06689956

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

Recruiting
Not specifiedAll AgesObservational
Mayo Clinic
~212 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
13 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence-free survival (RFS)
Measured over Up to 5 years

Conditions

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

Explore related trials

Endometrial Carcinoma

Where it's being run

20 sites across 18 states
MI2
Spain2
Minnesota1
New York1
Texas1
Austria1
Brazil1
Ontario1

Study leadership

  • Gretchen E. Glaser, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Recurrence-free survival (RFS)Up to 5 years

    RFS is defined as the length of time after primary treatment that the patient survives without any signs or symptoms of that cancer. (Recurrence may be vaginal, hematogenous, lymphatic, or peritoneal.) RFS will be measured from the date of surgery to the date of recurrence, death, or last disease evaluation.