Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT)
1 other identifier
observational
1,715
4 countries
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 26, 2020
CompletedFirst Submitted
Initial submission to the registry
February 27, 2020
CompletedFirst Posted
Study publicly available on registry
March 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 26, 2027
April 1, 2026
March 1, 2026
7 years
February 27, 2020
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of pelvic/non-vaginal recurrence at 36 months
Participants will be assessed every 6 (+/- 2) months for 36 months through routine physical examination
36 months
Study Arms (2)
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)
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, 06102, United States
University of Miami (Data Collection Only)
Miami, Florida, 33136, United States
Miami Cancer Institute Baptist Health South Florida
Miami, Florida, 33143, United States
ADVENTHEALTH (Data collection only)
Orlando, Florida, 32804, United States
Mayo Clinic (Data Collection and Data Analysis)
Rochester, Minnesota, 55905, United States
Memorial Sloan Kettering Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Charles University and General University Hospital (Data Collection Only)
Prague, Czechia
OSPEDALE MICHELE E PIETRO (Data Collection Only)
Ferrera, Italy
UNIVERSITY OF MILANO-BICOCCA, ITALY (Data Collection)
Milan, Italy
FONDAZIONE POLICLINICOUNIVERSITARIO A. GEMELLI, ITALY (Data Collection Only)
Roma, Italy
L'Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy
OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only)
Oslo, Norway
Related Publications (1)
Grassi T, Mariani A, Cibula D, Soliman PT, Suman VJ, Weaver AL, Pedra Nobre S, Weigelt B, Glaser GE, Cappuccio S, Abu-Rustum NR. A prospective multicenter international single-arm observational study on the oncological safety of the sentinel lymph node algorithm in stage I intermediate-risk endometrial cancer (SELECT, SEntinel Lymph node Endometrial Cancer Trial). Int J Gynecol Cancer. 2020 Oct;30(10):1627-1632. doi: 10.1136/ijgc-2020-001698. Epub 2020 Jul 22.
PMID: 32699021DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadeem Abu-Rustum, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2020
First Posted
March 2, 2020
Study Start
February 26, 2020
Primary Completion (Estimated)
February 26, 2027
Study Completion (Estimated)
February 26, 2027
Last Updated
April 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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.