Actively Recruiting

Age: 18Years +
FEMALE
ID04291612

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-01

1715

Participants Needed

19

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying women diagnosed with endometrial cancer, specifically endometrioid adenocarcinoma, to understand how often the cancer returns after receiving the standard treatment. The study also aims to find out how often the standard treatment leads to lymphedema, which is swelling caused by lymph fluid buildup. This observational trial is led by Memorial Sloan Kettering Cancer Center and focuses on patients treated with surgery and sentinel lymph node biopsy. Participants will undergo planned surgical treatment that includes a hysterectomy combined with sentinel lymph node (SLN) biopsy and bilateral salpingo-oophorectomy. The study has two parts: part 1 involves diagnosis and surgical treatment, while part 2 involves clinical follow-up for relapse through physical exams over 30 months after surgery. Only patients with negative sentinel lymph nodes for cancer cells are included in the follow-up group. During the study, participants will have regular physical examinations to monitor for signs of cancer recurrence, especially in the pelvis or other non-vaginal areas. Researchers will track the incidence of cancer returning within 36 months after surgery. The study also involves evaluating the occurrence of lymphedema and other clinical outcomes. Participants will be monitored for at least 30 months post-surgery to gather this information.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • ECOG performance status 0-1 or KPS 6 70%
  • Age 18 years or older
  • Diagnosis of endometrioid adenocarcinoma confirmed by biopsy or curettage
  • No evidence of disease outside the uterus or suspicious lymph nodes on imaging and physical exam
  • Suitable candidate for surgery
  • Planned surgical treatment including hysterectomy with sentinel lymph node biopsy and bilateral salpingo-oophorectomy
  • No history of second primary cancer (except non-melanoma skin cancer) within past 5 years
  • No prior neoadjuvant chemotherapy or radiotherapy for endometrial cancer
  • No prior pelvic or abdominal radiotherapy
  • At surgery, must undergo hysterectomy, bilateral salpingo-oophorectomy (unless already performed), and bilateral pelvic sentinel lymph node mapping with negative nodes
  • Final pathology showing stage I intermediate-risk endometrial endometrioid cancer with negative pelvic peritoneal cytology
  • Adjuvant treatment limited to none or intravaginal radiation only
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Evidence of extrauterine disease, gross lymph node involvement, or cervical invasion suspected before surgery
  • Contraindications for sentinel lymph node mapping
  • Planned treatment other than surgery or surgery without hysterectomy combined with sentinel lymph node biopsy and bilateral salpingo-oophorectomy
  • Intra-operative detection of extra-uterine disease or grossly involved lymph nodes
  • Presence of positive pelvic lymph nodes including micrometastasis or isolated tumor cells
  • Hysterectomy not performed
  • Bilateral salpingo-oophorectomy not performed unless already done
  • Failed unilateral or bilateral sentinel lymph node mapping
  • Undergoing complete pelvic lymphadenectomy
  • Undergoing radical type C hysterectomy
  • Low-risk stage IA endometrioid cancer or stage IB grade 3 endometrioid cancer
  • Non-endometrioid histology such as serous, clear cell, carcinosarcoma, or undifferentiated types
  • Empty unilateral or bilateral sentinel lymph node packets
  • Positive peritoneal cytology

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo planned surgical treatment including hysterectomy with sentinel lymph node biopsy and bilateral salpingo-oophorectomy.

1 visit (in-person)

Long-term Monitoring

Duration - 30 months

Participants are prospectively followed clinically for relapse with physical exams at post-operative visits for up to 30 months after surgery.

Regular post-operative visits for physical exam

Trial Site Locations

Total: 19 locations

1

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, United States, 06102

Actively Recruiting

2

University of Miami (Data Collection Only)

Miami, Florida, United States, 33136

Not Yet Recruiting

3

Miami Cancer Institute Baptist Health South Florida

Miami, Florida, United States, 33143

Actively Recruiting

4

ADVENTHEALTH (Data collection only)

Orlando, Florida, United States, 32804

Actively Recruiting

5

Mayo Clinic (Data Collection and Data Analysis)

Rochester, Minnesota, United States, 55905

Active, Not Recruiting

6

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

7

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

8

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

9

Memorial Sloan Kettering Commack (All Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

10

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, United States, 10604

Actively Recruiting

11

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

12

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, United States, 11553

Actively Recruiting

13

Lehigh Valley Health Network

Allentown, Pennsylvania, United States, 18103

Actively Recruiting

14

Charles University and General University Hospital (Data Collection Only)

Prague, Czechia

Terminated

15

OSPEDALE MICHELE E PIETRO (Data Collection Only)

Ferrera, Italy

Actively Recruiting

16

UNIVERSITY OF MILANO-BICOCCA, ITALY (Data Collection)

Milan, Italy

Not Yet Recruiting

17

FONDAZIONE POLICLINICOUNIVERSITARIO A. GEMELLI, ITALY (Data Collection Only)

Roma, Italy

Not Yet Recruiting

18

L'Azienda Sanitaria Universitaria Friuli Centrale

Udine, Italy

Actively Recruiting

19

OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only)

Oslo, Norway

Not Yet Recruiting

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Research Team

N

Nadeem Abu-Rustum, MD

M

Mario Leitao, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

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).

Tommaso Grassi, Andrea Mariani, David Cibula...

https://pubmed.ncbi.nlm.nih.gov/32699021