Endometrial CancerNCT04291612
Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
An observational study of Endometrial Cancer and Endometrioid Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 18 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Endometrioid Adenocarcinoma, Endometrial Cancer Stage I
- What is being tested?
- Physical exam
- How many people
- 1,715 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 26 Feb 2020to 26 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
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
Trial locations and contacts
18 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 5 countries
United States13 sites, 12 recruiting
- Recruiting
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Martin Martino, MD, 610-402-3650
- Recruiting
Memorial Sloan Kettering Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, 07920
Nadeem Abu-Rustum, MD, 212-639-7051
- Recruiting
Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, 11725
Nadeem Abu-Rustum, MD, 212-639-7051
- Recruiting
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604
Nadeem Abu-Rustum, MD, 212-639-7051
- Recruiting
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, 06102
Jonathan Cosin, MD, 860-826-1101
- Recruiting
Houston Methodist Cancer Center (Data Collection Only)
Houston, Texas, 77030
Pedro Ramirez, md, 713-441-1026
- Recruiting
Miami Cancer Institute Baptist Health South Florida
Miami, Florida, 33143
John Paul Diaz, MD, 786-596-2000
- Recruiting
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748
Nadeem Abu-Rustum, MD, 212-639-7051
- Recruiting
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645
Nadeem Abu-Rustum, MD, 212-639-7051
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Nadeem Abu-Rustum, MD, 212-639-7051
- Recruiting
ADVENTHEALTH (Data collection only)
Orlando, Florida, 32804
Robert Holloway, MD, 407-303-2422
- Active, not recruiting
Mayo Clinic (Data Collection and Data Analysis)
Rochester, Minnesota, 55905
- Recruiting
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553
Nadeem Abu-Rustum, MD, 212-639-7051
Italy2 sites, 2 recruiting
- Recruiting
OSPEDALE MICHELE E PIETRO (Data Collection Only)
Ferrera
Alessandro Buda, MD, 0173 290851
- Recruiting
L'Azienda Sanitaria Universitaria Friuli Centrale
Udine
Giuseppe Vizzielli, MD, giuseppe.vizzielli@asufc.sanita.fvg.it
Czechia1 site
- Terminated
Charles University and General University Hospital (Data Collection Only)
Prague
Norway1 site, 1 recruiting
- Not yet recruiting
OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only)
Oslo
Ane Gerda, MD, PhD, +47 22 93 44 46
Saudi Arabia1 site, 1 recruiting
- Not yet recruiting
Sulaiman Al Habib Medical Group
Khobar, Eastern Province
Sarah Al-Rubaish, MD
About this study
Official title: 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.
- Being tested
- Physical exam
- Keywords
- Endometrial Cancer, Endometrioid Adenocarcinoma, 20-067, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Endometrial Neoplasms, Carcinoma, Endometrioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical examOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Physical exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pelvic/non-vaginal recurrence at 36 months
Participants will be assessed every 6 (+/- 2) months for 36 months through routine physical examination
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start26 Feb 2020
- Primary completion26 Feb 2027 (estimated)
- Study completion26 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,715 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadeem Abu-Rustum, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291612
- Sponsor's protocol ID
- 20-067
- Status last verified
- Aug 2026
- First submitted
- 27 Feb 2020
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 32699021
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT)
- ClinicalTrials.gov ID
- NCT04291612
- Acronym / sponsor ID
- 20-067
- Keywords
- Endometrial Cancer, Endometrioid Adenocarcinoma, 20-067, Memorial Sloan Kettering Cancer Center
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,715 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 26 Feb 2027 (estimated)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | – | –Participants will have endometrioid adenocarcinoma histological diagnosis with planned surgical treatment including hysterectomy in combination with SLN biopsy. |
| Part 2 | – | Other: Physical examParticipants will have undergone surgery and bilateral sentinel lymph node mapping (negative for malignancy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical examPart 2 participants will be prospectively followed clinically for relapse for 30 months from the date of surgery for physical examination at post-ops visits. | Other | Part 2 |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Derived from this study: PubMed 32699021Grassi 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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadeem Abu-Rustum, MD principal investigator
Memorial Sloan Kettering Cancer Center
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer and Endometrioid Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 18 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Italy, Czechia, Norway, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadeem Abu-Rustum, MD (212-639-7051, abu-rusn@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pelvic/non-vaginal recurrence at 36 months (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04291612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.