Overview
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.
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.
Eligibility
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
- Non-endometrioid histology
- Endometrial cancer (FIGO) with one or more established risk factors:
- Preoperatively:
- 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