Endometrial Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 25-000815
NCT ID: NCT07062016
About this study
The purpose of this study is 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18 years
- Complete surgical staging at Mayo Clinic (MCR, MCA, MCF). 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 (FIGO staging used throughout this protocol)
- Preoperatively:
- Biopsy with grade 3 endometrioid EC or non-endometrioid EC
- Patients with FIGO grade 1-2 EC with evidence of extra-uterine 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
- Stage II to IV (FIGO) EC
- Provide written informed consent
-
Willingness to provide mandatory blood specimens for correlative research (see Section 14.0).
-
Willingness to provide mandatory tissue specimens for correlative research (see Section 17.0).
-
Willingness to return to registering site for clinical follow-up.
Exclusion Criteria:
- Patient receiving or who has received neoadjuvant chemotherapy
- Pre-operative population pregnant not an option
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 1/23/2025. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Andrea Mariani, M.D., M.S. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available