Molecular and ctDNA Characterization of High-Risk Endometrial Cancer
Purpose
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.
Conditions
- Endometrial Carcinoma
- Endometrial High Grade Endometrioid Adenocarcinoma
- Stage II Endometrial Cancer
- Stage III Endometrial Cancer
- Stage IV Endometrial Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Observational | Patients undergo blood and tissue sample collection and have their medical records reviewed throughout the study. |
|
Recruiting Locations
Rochester, Minnesota 55905
More Details
- Status
- Recruiting
- Sponsor
- Mayo Clinic
Detailed Description
PRIMARY OBJECTIVE: I. 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. OUTLINE: This is an observational study. Patients undergo blood and tissue sample collection and have their medical records reviewed throughout the study.