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NCT07062016Recruiting

Molecular and ctDNA Characterization of High-Risk Endometrial Cancer

Mayo Clinic

Start Date

10/1/2025

Completion Date

10/31/2028

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.

Detailed Description

PRIMARY OBJECTIVE: I. To generate preliminary data for a risk stratification model for recurrence including traditional histopathologic risk factors, molecular characterization in endometrial cancer patients with features of aggressive disease. OUTLINE: This is an observational study. Patients undergo blood and tissue sample collection and have their medical records reviewed throughout the study.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

OTHER

Non-Interventional Study

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Conditions

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

Locations

Mayo Clinic in Rochester

Rochester, Minnesota 55905

United States