Image

Molecular and ctDNA Characterization of High-Risk Endometrial Cancer

Molecular and ctDNA Characterization of High-Risk Endometrial Cancer

Recruiting
18 years and older
Female
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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 details
    Endometrial Carcinoma
    Endometrial High Grade Endometrioid Adenocarcinoma
    Stage II Endometrial Cancer
    Stage III Endometrial Cancer
    Stage IV Endometrial Cancer

NCT07062016

Mayo Clinic

15 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.