Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
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ClinicalTrials.gov Identifier: NCT04291612 |
Recruitment Status :
Recruiting
First Posted : March 2, 2020
Last Update Posted : May 9, 2023
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Condition or disease | Intervention/treatment |
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Endometrial Cancer Endometrioid Adenocarcinoma Endometrial Cancer Stage I | Other: Physical exam |
Study Type : | Observational |
Estimated Enrollment : | 1400 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT) |
Actual Study Start Date : | February 26, 2020 |
Estimated Primary Completion Date : | February 26, 2024 |
Estimated Study Completion Date : | February 26, 2024 |

Group/Cohort | Intervention/treatment |
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Part 1
Participants will have endometrioid adenocarcinoma histological diagnosis with planned surgical treatment including hysterectomy in combination with SLN biopsy.
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Part 2
Participants will have undergone surgery and bilateral sentinel lymph node mapping (negative for malignancy)
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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. |
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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:
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At surgery, the patient must undergo:
- Hysterectomy
- Bilateral salpingo-oophorectomy, unless already previously performed
- Bilateral pelvic SLN mapping (bilateral sentinel nodes are negative for malignancy)
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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
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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 previously 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04291612
Contact: Nadeem Abu-Rustum, MD | 212-639-7051 | abu-rusn@mskcc.org | |
Contact: Mario Leitao, MD | 212-639-3987 | leitaom@mskcc.org |

Principal Investigator: | Nadeem Abu-Rustum, MD | Memorial Sloan Kettering Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT04291612 |
Other Study ID Numbers: |
20-067 |
First Posted: | March 2, 2020 Key Record Dates |
Last Update Posted: | May 9, 2023 |
Last Verified: | May 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Endometrial Cancer Endometrioid Adenocarcinoma 20-067 Memorial Sloan Kettering Cancer Center |
Adenocarcinoma Endometrial Neoplasms Carcinoma, Endometrioid Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Uterine Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Ovarian Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |