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

February 17, 2026 updated by: Mayo Clinic

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Vienna, Austria
        • Recruiting
        • Medical University of Vienna
        • Principal Investigator:
          • Christoph Grimm, MD
        • Contact:
  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • AC Camargo Cancer Center
        • Contact:
        • Principal Investigator:
          • Glauco Baiocchi, MD, PhD
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences, University of Toronto
        • Contact:
        • Principal Investigator:
          • Allan Covens, MD
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Hopital Maisonneuve Rosemont
        • Contact:
        • Principal Investigator:
          • Sabrina Piedimonte, MD
  • France
      • Toulouse, France, 31100
        • Not yet recruiting
        • Institut Universitaire du Cancer Toulouse Oncopole
        • Contact:
        • Principal Investigator:
          • Giulio Ricotta, MD
  • Germany
      • Essen, Germany, 45147
        • Not yet recruiting
        • University Hospital Essen
        • Contact:
        • Principal Investigator:
          • Paul Buderath, MD
  • Israel
      • Kefar Sava, Israel
        • Not yet recruiting
        • Meir Medical Center, Faculty of Medicine - Tel-Aviv University
        • Contact:
        • Principal Investigator:
          • Mario Beiner, MD
  • Italy
      • Naples, Italy, 80131
        • Not yet recruiting
        • Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
        • Contact:
        • Principal Investigator:
          • Vito Chiantera, MD
    • CN
      • Verduno, CN, Italy, 12060
        • Not yet recruiting
        • Ospedale Michele e Pietro Ferrero
        • Contact:
        • Principal Investigator:
          • Alessandro Buda, MD
    • MB
      • Monza, MB, Italy, 20900
        • Not yet recruiting
        • IRCCS Fondazione San Gerardo dei Tintori
        • Contact:
        • Principal Investigator:
          • Fabio Landon, MD
    • MI
      • Milan, MI, Italy, 20141
        • Recruiting
        • European Institute of Oncology
        • Contact:
        • Principal Investigator:
          • Francesco Multinu, MD
      • Milan, MI, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale Tumori
        • Contact:
        • Principal Investigator:
          • Francesco Raspagliesi, MD
    • RM
      • Roma, RM, Italy, 00168
        • Recruiting
        • Policlinico Universitario Fondazione Agostino Gemelli
        • Contact:
        • Principal Investigator:
          • Francesco Fanfani, MD
    • UD
      • Udine, UD, Italy, 33100
        • Not yet recruiting
        • University of Udine
        • Contact:
        • Principal Investigator:
          • Giuseppe Vizzielli, MD, PhD
  • Spain
      • Las Palmas, Spain, 35016
        • Recruiting
        • Hospital Materno Infantil Las Palmas
        • Contact:
        • Principal Investigator:
          • Octavio Arencibia Sanchez, MD, PhD
      • Madrid, Spain, 28029
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
        • Principal Investigator:
          • Ignacio Zapardiel, MD
  • Switzerland
      • Lugano, Switzerland, 6900
        • Recruiting
        • Ospedale Regionale di Lugano, Civico
        • Contact:
        • Principal Investigator:
          • Andrea Papadia, MD, PhD
  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Gretchen E. Glaser, MD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
        • Principal Investigator:
          • Nadeem R. Abu-Rustum, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Pedro T. Ramirez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with low-risk endometrial cancer.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Observational
Patients undergo tissue sample collection and have their medical records reviewed on study.
Other: Non-Interventional Study
Non-Interventional Study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recurrence-free survival (RFS)
Time Frame: 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.
Up to 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Non-vaginal RFS
Time Frame: Up to 5 years
Non-vaginal RFS is defined as the interval from the date of surgery to the date of the first of the following events: non-vaginal recurrence or death due to any cause.
Up to 5 years
Overall Survival (OS)
Time Frame: Up to 5 years
Overall survival is defined as the time from surgery to death due to any cause.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gretchen E. Glaser, MD, Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-008963 (Other Identifier: Mayo Clinic in Rochester)
  • NCI-2024-09016 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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