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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 histologic subtype, FIGO grade 1 or 2, FIGO 2009 stage IA, without substantial lymphovascular space invasion at final pathology.
  • Complete surgical staging, including pelvic SLN biopsy according to NCCN protocol and ultrastaging.
  • ITC (defined as metastases ≤0.2 mm or 0.2 to ≤2.0 mm) or macrometastases (>2.0 mm) in SLN.
  • Acceptance to participate in the study.

Exclusion criteria:

  • Neoadjuvant chemotherapy.
  • Synchronous cancer, defined as the presence of any invasive primary or recurrent cancer diagnosed in the 90 days prior to enrollment or at the time of surgery.
  • Presence of micrometastases (>0.2 to ≤2.0 mm) or macrometastases (>2.0 mm) in SLN.

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

Eligibility last updated 8/29/23. 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

More information

Publications

Publications are currently not available

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CLS-20565077

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