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Molecular and ctDNA Characterization of High-Risk Endometrial Cancer
RECRUITINGSponsored by Mayo Clinic
Actively Recruiting
SponsorMayo Clinic
Started2025-10-01
Est. completion2028-10-31
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07062016
Summary
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
Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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 pregnancyConditions6
CancerEndometrial CarcinomaEndometrial High Grade Endometrioid AdenocarcinomaStage II Endometrial CancerStage III Endometrial CancerStage IV Endometrial Cancer
Locations1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
SponsorMayo Clinic
Started2025-10-01
Est. completion2028-10-31
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07062016