Molecular and ctDNA Characterization of High-Risk Endometrial Cancer

Launched by MAYO CLINIC · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying high-risk endometrial cancer, a type of cancer that starts in the lining of the uterus. The main goal is to learn more about why this cancer sometimes comes back after treatment. Researchers will look at genetic information from the cancer and blood samples to find specific genetic changes that might help doctors better diagnose, treat, and predict outcomes for patients. The study will also create a database of genetic and medical information to help with future research.

Women aged 18 and older who are diagnosed with aggressive forms of endometrial cancer and are planning to have surgery at the Mayo Clinic may be eligible to join. To qualify, patients must be undergoing a thorough surgical procedure to remove the uterus and related tissues, and their cancer must show certain risk factors, such as advanced stage or aggressive tumor features. Participants will need to provide blood and tissue samples for research and agree to follow-up visits after surgery. This trial is not yet recruiting, but it offers an important opportunity to help improve care for women with high-risk endometrial cancer.

Gender

FEMALE

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