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RecruitingNCT07062016

Molecular and ctDNA Characterization of High-Risk Endometrial Cancer

MC230601 Molecular and ctDNA Characterization of High-Risk Endometrial Cancer

Sponsor

Mayo Clinic

Enrollment

100 participants

Start Date

Oct 1, 2025

Study Type

OBSERVATIONAL

Conditions

Endometrial CarcinomaEndometrial High Grade Endometrioid AdenocarcinomaStage II Endometrial CancerStage III Endometrial CancerStage IV Endometrial Cancer

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria16

  • 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 Criteria2

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

Interventions

OTHERNon-Interventional Study

Non-interventional study

Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT07062016

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