Molecular and ctDNA Characterization of High-Risk Endometrial Cancer

Not yet recruiting

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

• Registration Number: NCT07062016
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Study Start: 2025-08-31
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival (RFS)	Up to 3 years	Defined as time from primary staging surgery to recurrence or death.
Presence of somatic and germline pathogenic variants	Up to 3 years	For each participant, a surgical tissue sample (OncoExtra) and a presurgical blood sample (RiskGuard) sample will be utilized to determine the presence of somatic and germline pathogenic variants. The count and percentage of patients with the presence of somatic or germline variants will be reported by The Cancer Genome Atlas (TGCA) class. The number, type, and function of somatic variants will also be reported by TGCA class. For genes with alterations seen in at least 10 patients, a log rank test will be used to assess whether RFS differs with respect to whether an alternation is present or not.

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States