Molecular and ctDNA profiling for high-risk endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study at Mayo Clinic collects blood (for circulating tumor DNA) and tumor tissue and reviews medical records from adults with high-risk endometrial cancer who undergo complete surgical staging. Researchers will perform molecular and genetic analyses to identify hereditary and tumor-specific variants and correlate these findings with clinical features and outcomes. The goal is to generate preliminary data to build a risk‑stratification model for recurrence using traditional pathology plus molecular markers. Samples and genetic results will be stored in a databank to support future research.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Evelyn A. Reynolds, MD — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.