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Molecular and ctDNA Characterization of High-Risk Endometrial Cancer

RecruitingObservational study

MC230601 Molecular and ctDNA Characterization of High-Risk Endometrial Cancer

Who can join

Ages 18 and older · Women

Full eligibility criteria
Inclusion Criteria:

* Age ≥ 18 years
* Planned complete surgical staging at Mayo Clinic. Complete surgical staging includes at least total hysterectomy, bilateral salpingo-oophorectomy and lymph node assessment. Sentinel node mapping meets the criteria for lymph node assessment. Peritoneal cytology is recommended. Additional staging procedures such as pelvic and para-aortic nodal evaluation, omental biopsy or omentectomy, may also be utilized for staging in patients based on the clinical situation and at the surgeon's discretion
* At least one preoperative or postoperative feature of aggressive disease \[International Federation of Gynecology and Obstetrics (FIGO) staging used throughout this protocol\]

  * Preoperatively:

    * Biopsy with grade 3 endometrioid endometrial cancer (EC) or non-endometrioid EC
    * Patients with FIGO grade 1-2 EC with evidence of extrauterine disease on imaging (CT, MRI, or PET)
  * Postoperatively:

    * Endometrial cancer (FIGO) with one or more established risk factors:

      * Non-endometrioid histology

        * Grade 3
      * Lymphovascular space invasion (LVSI), ≥ 50% of myometrial invasion, presence of isolated tumor cells (ITC) in a sentinel lymph node OR
      * Stage II to IV (FIGO) EC
* Provide written informed consent
* Willingness to provide mandatory blood specimens for correlative research
* Willingness to provide mandatory tissue specimens for correlative research
* Willingness to return to registering site for clinical follow-up

Exclusion Criteria:

* Patient receiving or who has received neoadjuvant chemotherapy
* Pre-operative pregnancy

About the study

This study seeks to better understand the recurrence of high-risk endometrial cancer. It will collect information about cancer genetics to find out various hereditary or cancer specific genetic variants that may have a role in diagnosis or management and prognosis of cancer. It also seeks to develop a genetic results and medical record databank for future studies.

What is being tested

Sponsor: Mayo Clinic · Participants: 100 · Started: Oct 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07062016

Locations in the U.S.

MinnesotaMayo Clinic in Rochester, Rochester

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.