Molecular and ctDNA Characterization of High-Risk Endometrial Cancer

Mayo Clinic

Status: Begins enrollment this month

Conditions: Stage II Endometrial Cancer; Endometrial Carcinoma; Stage IV Endometrial Cancer; Endometrial High Grade Endometrioid Adenocarcinoma; Stage III Endometrial Cancer

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT07062016

25-000815 (Other Identifier)

MC230601 (Other Identifier)

NCI-2025-04532 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Observational

Description:

Patients undergo blood and tissue sample collection and have their medical records reviewed throughout the study.

Treatment:

Other: Non-Interventional Study