NCT07062016 Molecular and ctDNA Characterization of High-Risk Endometrial Cancer
| NCT ID | NCT07062016 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Endometrial Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-10-01 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Evelyn A. Reynolds, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT07062016 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07062016 currently recruiting?
Yes, NCT07062016 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT07062016 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07062016 clinical trial?
NCT07062016 is sponsored by Mayo Clinic. The principal investigator is Evelyn A. Reynolds, MD at Mayo Clinic in Rochester. The trial plans to enroll 100 participants.