What this study is
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.
What's being tested
- Non-Interventional Study
Intervention · OTHER
Non-interventional study
Study details
- Official title
- MC230601 Molecular and ctDNA Characterization of High-Risk Endometrial Cancer
- Sponsor
- Mayo Clinic
- Conditions
- Endometrial Carcinoma · Endometrial High Grade Endometrioid Adenocarcinoma · Stage II Endometrial Cancer · Stage III Endometrial Cancer · Stage IV Endometrial Cancer
- Enrolling
- 100 people
- Starts
- 2025-10-01
- Est. completion
- 2028-10-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Patient receiving or who has received neoadjuvant chemotherapy
- Pre-operative pregnancy
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic in Rochester
Rochester, Minnesota, United States
- Clinical Trials Referral Office · Contact855-776-0015mayocliniccancerstudies@mayo.edu
- Evelyn A. Reynolds, MD · Principal investigator
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID MC230601
Principal investigator
Evelyn A. Reynolds, MD
Mayo Clinic in Rochester
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.