Molecular and ctDNA Characterization of High-Risk Endometrial Cancer

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.

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