About this trial
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
This trial does not accept healthy volunteersQualifiers
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]
Biopsy with grade 3 endometrioid endometrial cancer (EC) or non-endometrioid EC
Disqualifiers
Patient receiving or who has received neoadjuvant chemotherapy
Pre-operative pregnancy
Trial population
Endometrial cancer patients with aggressive disease and planned complete surgical staging at Mayo Clinic.
Trial design
Cohort
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
Trial outcomes
Primary outcomes
Recurrence-free survival (RFS)
Defined as time from primary staging surgery to recurrence or death.
Presence of somatic and germline pathogenic variants
For each participant, a surgical tissue sample (OncoExtra) and a presurgical blood sample (RiskGuard) sample will be utilized to determine the presence of somatic and germline pathogenic variants. The count and percentage of patients with the presence of somatic or germline variants will be reported by The Cancer Genome Atlas (TGCA) class. The number, type, and function of somatic variants will also be reported by TGCA class. For genes with alterations seen in at least 10 patients, a log rank test will be used to assess whether RFS differs with respect to whether an alternation is present or not.
Sponsors and contacts
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