NCT07062016 · Mayo Clinic
Molecular and ctDNA Characterization of High-Risk Endometrial Cancer
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Non-Interventional Study
Non-interventional study
Primary outcome measures
Recurrence-free survival (RFS)
Time frame: Up to 3 years
Defined as time from primary staging surgery to recurrence or death.
Presence of somatic and germline pathogenic variants
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations