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

Last updated: February 17, 2026
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometrial Cancer

Adenocarcinoma

Treatment

Non-Interventional Study

Clinical Study ID

NCT06689956
23-008963
NCI-2024-09016
23-008963
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Low-risk endometrial cancer, defined as endometrioid, grade 1 or 2, InternationalFederation of Gynecology and Obstetrics (FIGO) 2009 stage IA (FIGO 2023 stages IA1and IA2), without substantial/extensive LVSI (≥ 5 vessels involved) at finalpathology. Patients with focal LVSI (< 5 vessels involved) will be included.

  • Complete surgical staging, including pelvic sentinel lymph node (SLN) biopsyper 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

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) ormacrometastasis (> 2.0 mm).

  • Presence of substantial/extensive LVSI (≥ 5 vessels involved) at finalpathology.

  • Prior invasive cancer diagnosis within 5 years of study entry (excludingnon-melanoma skin cancer).

Study Design

Total Participants: 212
Treatment Group(s): 1
Primary Treatment: Non-Interventional Study
Phase:
Study Start date:
December 04, 2024
Estimated Completion Date:
October 31, 2029

Study 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.

Connect with a study center

  • Medical University of Vienna

    Vienna,
    Austria

    Site Not Available

  • Medical University of Vienna

    Vienna 2761369,
    Austria

    Active - Recruiting

  • AC Camargo Cancer Center

    São Paulo,
    Brazil

    Site Not Available

  • AC Camargo Cancer Center

    São Paulo 3448439,
    Brazil

    Active - Recruiting

  • Sunnybrook Health Sciences, University of Toronto

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Sunnybrook Health Sciences, University of Toronto

    Toronto 6167865, Ontario 6093943 M4N 3M5
    Canada

    Active - Recruiting

  • Hopital Maisonneuve Rosemont

    Montréal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Hopital Maisonneuve Rosemont

    Montreal 6077243, Quebec 6115047 H1T 2M4
    Canada

    Active - Recruiting

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31100
    France

    Site Not Available

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse 2972315, 31100
    France

    Site Not Available

  • University Hospital Essen

    Essen, 45147
    Germany

    Site Not Available

  • University Hospital Essen

    Essen 2928810, 45147
    Germany

    Site Not Available

  • Meir Medical Center, Faculty of Medicine - Tel-Aviv University

    Kefar Sava,
    Israel

    Site Not Available

  • Meir Medical Center, Faculty of Medicine - Tel-Aviv University

    Kefar Sava 294514,
    Israel

    Site Not Available

  • Ospedale Michele e Pietro Ferrero

    Verduno, CN 12060
    Italy

    Site Not Available

  • Ospedale Michele e Pietro Ferrero

    Verduno 6534852, CN 12060
    Italy

    Site Not Available

  • IRCCS Fondazione San Gerardo dei Tintori

    Monza, MB 20900
    Italy

    Site Not Available

  • IRCCS Fondazione San Gerardo dei Tintori

    Monza 3172629, MB 20900
    Italy

    Site Not Available

  • European Institute of Oncology

    Milan 6951411, MI 20141
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milan 6951411, MI 20133
    Italy

    Active - Recruiting

  • European Institute of Oncology

    Milano, MI 20141
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milano, MI 20133
    Italy

    Site Not Available

  • Policlinico Universitario Fondazione Agostino Gemelli

    Roma, RM 00168
    Italy

    Site Not Available

  • Policlinico Universitario Fondazione Agostino Gemelli

    Roma 8957247, RM 00168
    Italy

    Active - Recruiting

  • University of Udine

    Udine, UD 33100
    Italy

    Site Not Available

  • University of Udine

    Udine 3165072, UD 33100
    Italy

    Site Not Available

  • Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale

    Naples, 80131
    Italy

    Site Not Available

  • Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale

    Naples 3172394, 80131
    Italy

    Site Not Available

  • Hospital Materno of Las Palmas

    Las Palmas, 35016
    Spain

    Site Not Available

  • Hospital Materno Infantil Las Palmas

    Las Palmas 2515272, 35016
    Spain

    Active - Recruiting

  • Hospital Materno of Las Palmas

    Las Palmas 2515272, 35016
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28029
    Spain

    Site Not Available

  • La Paz University Hospital-IdiPAZ

    Madrid, 28029
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid 3117735, 28029
    Spain

    Active - Recruiting

  • Ospedale Regionale di Lugano, Civico

    Lugano, 6900
    Switzerland

    Site Not Available

  • Ospedale Regionale di Lugano, Civico

    Lugano 2659836, 6900
    Switzerland

    Active - Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic in Rochester

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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