Outcomes of low-risk endometrial cancer with isolated tumor cells in the sentinel lymph nodes: a prospective multicenter single-arm observational study

Overview

About this study

The purpose of this study is to prospectively evaluate the prognostic role of ITC versus negative nodes in patients with low-risk endometrial cancer who undergo SLN biopsy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

* Low-risk endometrial cancer, defined as endometrioid, grade 1 or 2, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA (FIGO 2023 stages IA1 and IA2), without substantial/extensive LVSI (≥ 5 vessels involved) at final pathology. Patients with focal LVSI (\< 5 vessels involved) will be included.

* Complete surgical staging, including pelvic sentinel lymph node (SLN) biopsy per National Comprehensive Cancer Network (NCCN) guidelines and ultrastaging.
* Extent of disease in SLN: ITC (defined as tumor cell aggregates ≤ 0.2 mm or \< 200 cells) identified in SLN.
* Willingness to forego adjuvant treatment.
* Research consent provided.

Exclusion Criteria:

* Prior neoadjuvant chemotherapy.

* Planning to receiving adjuvant treatment.
* Presence of synchronous cancer.
* Extent of disease in SLN: micrometastasis (\> 0.2 to ≤ 2.0 mm) or macrometastasis (\> 2.0 mm).
* Presence of substantial/extensive LVSI (≥ 5 vessels involved) at final pathology.
* No prior invasive cancer diagnosis within 5 years of study entry.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/14/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Gretchen Glaser, M.D.	Open for enrollment	Contact information: Gretchen Glaser M.D. (507) 538-5905 Glaser.Gretchen@mayo.edu
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Kristina Butler, M.D., M.S.	Contact us for the latest status	Contact information: Kristina Butler M.D., M.S. (480) 301-8000 Butler.Kristina@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Gretchen Glaser, M.D.

Open for enrollment

Contact information:

Gretchen Glaser M.D.

(507) 538-5905

Glaser.Gretchen@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Kristina Butler, M.D., M.S.

Contact us for the latest status

Contact information:

Kristina Butler M.D., M.S.

(480) 301-8000

Butler.Kristina@mayo.edu

More information

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