Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease

March 27, 2026 updated by: Memorial Sloan Kettering Cancer Center

SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT)

This study is being done to find out how often endometrial cancer recurs after the standard treatment as well as how often the standard treatment results in a lymphedema.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1715

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 Backup

Study Locations

  • Czechia
      • Prague, Czechia
        • Terminated
        • Charles University and General University Hospital (Data Collection Only)
  • Italy
      • Ferrera, Italy
        • Recruiting
        • OSPEDALE MICHELE E PIETRO (Data Collection Only)
        • Contact:
          • Alessandro Buda, MD
          • Phone Number: 0173 290851
      • Milan, Italy
        • Not yet recruiting
        • UNIVERSITY OF MILANO-BICOCCA, ITALY (Data Collection)
        • Contact:
          • Tommaso Grassi, MD
          • Phone Number: +39 02 6448 6099
      • Roma, Italy
        • Not yet recruiting
        • FONDAZIONE POLICLINICOUNIVERSITARIO A. GEMELLI, ITALY (Data Collection Only)
        • Contact:
          • Giovanni Scambia, MD
          • Phone Number: 39 06 30151
      • Udine, Italy
  • Norway
      • Oslo, Norway
        • Not yet recruiting
        • OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only)
        • Contact:
          • Ane Gerda, MD, PhD
          • Phone Number: +47 22 93 44 46
  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Healthcare Cancer Institute @ Hartford Hospital
        • Contact:
          • Jonathan Cosin, MD
          • Phone Number: 860-826-1101
    • Florida
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • University of Miami (Data Collection Only)
        • Contact:
          • Brian Clomovitz, MD
          • Phone Number: 305-243-2233
      • Miami, Florida, United States, 33143
        • Recruiting
        • Miami Cancer Institute Baptist Health South Florida
        • Contact:
          • John Paul Diaz, MD
          • Phone Number: 786-596-2000
      • Orlando, Florida, United States, 32804
        • Recruiting
        • ADVENTHEALTH (Data collection only)
        • Contact:
          • Robert Holloway, MD
          • Phone Number: 407-303-2422
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Active, not recruiting
        • Mayo Clinic (Data Collection and Data Analysis)
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
        • Contact:
          • Nadeem Abu-Rustum, MD
          • Phone Number: 212-639-7051
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (All Protocol Activities)
        • Contact:
          • Nadeem Abu-Rustum, MD
          • Phone Number: 212-639-7051
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (All Protocol Activities)
        • Contact:
          • Nadeem Abu-Rustum, MD
          • Phone Number: 212-639-7051
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack (All Protocol Activities)
        • Contact:
          • Nadeem Abu-Rustum, MD
          • Phone Number: 212-639-7051
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (All Protocol Activities)
        • Contact:
          • Nadeem Abu-Rustum, MD
          • Phone Number: 212-639-7051
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Nadeem Abu-Rustum, MD
          • Phone Number: 212-639-7051
      • Rockville Centre, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (All Protocol Activities)
        • Contact:
          • Nadeem Abu-Rustum, MD
          • Phone Number: 212-639-7051
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Health Network
        • Contact:
          • Martin Martino, MD
          • Phone Number: 610-402-3650

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or a member of the research teams. If the investigator is a member of the treatment team, s/he will screen their patients' medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study. The principal investigators may also screen the medical records of patients with whom they do not have a treatment relationship for the limited purpose of identifying patients who would be eligible to enroll in the study, and to record appropriate contact information in order to approach these patients regarding the possibility of enrolling in the study. Patients identified in this manner would subsequently be approached for study enrollment after consultation with their treating physician.

Description

Screening Inclusion Criteria:

  • ECOG performance status 0-1 or KPS ≥ 70%
  • Age ≥ 18 years
  • Endometrioid adenocarcinoma histologic diagnosis on endometrial biopsy or dilatation and curettage
  • No evidence of extrauterine disease, or suspicious pelvic lymph nodes, or distant metastases, or cervical invasion on pre-operative conventional imaging studies (Pelvic +/- Abdomen CT or MRI or sonogram, or body PET scan) and physical examination (uterine confined by exam and imaging )
  • Suitable candidate for surgery
  • Planned surgical treatment including hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy
  • No history of second primary cancer (invasive or in situ) within the past 5 years, not including non-melanoma skin cancer
  • Approved and signed informed consent
  • No history of neoadjuvant chemotherapy or radiotherapy for endometrial cancer
  • No history of prior pelvic or abdominal radiotherapy

Screening Exclusion Criteria:

  • Extrauterine disease, or gross lymph node involvement, or cervical invasion suspected on pre-operative imaging studies and physical examination (disease not uterine confined clinical stage > I)
  • Contraindication for SLN mapping
  • The planned treatment is not surgery, or the surgical treatment does not include hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy

Eligibility Inclusion Criteria

Patients will be classified in the study cohort (part 2; n=182) according to surgical treatment received, final post hysterectomy and staging pathologic report, and planned adjuvant treatment. The inclusion criteria are specified below.

Study Cohort (n=182)

A patient will be enrolled in the study cohort if all the following criteria are met:

  • At surgery, the patient must undergo:

    • Hysterectomy
    • Bilateral salpingo-oophorectomy, unless already performed (including allowing unilateral salpingo-oophorectomy if unilateral salpingo-oophorectomy already performed)
    • Bilateral pelvic SLN mapping (bilateral sentinel nodes are negative for malignancy)

  • On the final pathologic report, the patient must have a diagnosis of:

    • Stage I intermediate-risk endometrial endometrioid cancer (Grade 1 or Grade 2 with ≥ 50% myometrial invasion or Grade 3 with <50% myometrial invasion, including non-invasive disease)
    • Negative pelvic peritoneal cytology

  • Adjuvant treatment as recommended by the multidisciplinary team must be as follows:

    • No adjuvant treatment, or
    • Intravaginal radiation only

Eligibility Exclusion Criteria

  • There is intra-operative detection of extra-uterine disease or grossly involved lymph nodes
  • Presence of any positive pelvic nodes including micrometastasis and isolated tumor cells (ITC)
  • Hysterectomy is not performed
  • Bilateral salpingo-oophorectomy is not performed, unless already performed (unilateral salpingo-oophorectomy is allowed if unilateral salpingo-oophorectomy already performed)
  • Failed unilateral or bilateral SLN mapping
  • Patient undergoes a complete unilateral or bilateral pelvic lymphadenectomy
  • Patient undergoes a radical type C hysterectomy
  • Stage IA endometrioid cancer Grade1 or 2 and myometrial invasion <50%
  • Stage IB Grade 3 endometrioid cancer
  • Non-endometrioid histology: Serous, clear cell, carcinosarcoma, undifferentiated, or de-differentiated histology noted on final hysterectomy pathology
  • Empty unilateral or bilateral sentinel lymph nodal packet(s)
  • Positive peritoneal cytology

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Part 1
Participants will have endometrioid adenocarcinoma histological diagnosis with planned surgical treatment including hysterectomy in combination with SLN biopsy.
Part 2
Participants will have undergone surgery and bilateral sentinel lymph node mapping (negative for malignancy)
Other: Physical exam
Part 2 participants will be prospectively followed clinically for relapse for 30 months from the date of surgery for physical examination at post-ops visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of pelvic/non-vaginal recurrence at 36 months
Time Frame: 36 months
Participants will be assessed every 6 (+/- 2) months for 36 months through routine physical examination
36 months

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Nadeem Abu-Rustum, MD, Memorial Sloan Kettering Cancer Center

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)

February 26, 2020

Primary Completion (Estimated)

February 26, 2027

Study Completion (Estimated)

February 26, 2027

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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.

Clinical Trials on Endometrial Cancer

Clinical Trials on Physical exam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe