Molecular and ctDNA profiling for high-risk endometrial cancer
MC230601 Molecular and ctDNA Characterization of High-Risk Endometrial Cancer
This project will collect blood and tumor tissue to test whether tumor DNA and other genetic changes can help predict recurrence in people with high-risk endometrial cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07062016 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age ≥18) with features of aggressive endometrial cancer who are planning complete surgical staging at Mayo Clinic in Rochester are the intended participants.
Not a fit: Patients with low‑risk early-stage endometrioid cancer or those not undergoing surgery or unable to provide tissue/blood samples are unlikely to gain direct benefit from this project.
Why it matters
Potential benefit: If successful, the work could help clinicians identify patients at higher risk of recurrence so follow-up and treatments can be better tailored.
How similar studies have performed: Molecular profiling and ctDNA approaches have shown promise in other cancers and early endometrial work, but these techniques are still emerging and not yet standard clinical practice.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.