Molecular and ctDNA Characterization of High-Risk Endometrial Cancer
NCT ID: NCT07062016
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-10-01
2028-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational
Patients undergo blood and tissue sample collection and have their medical records reviewed throughout the study.
Non-Interventional Study
Non-interventional study
Interventions
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Non-Interventional Study
Non-interventional study
Eligibility Criteria
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Inclusion Criteria
* 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
* Pre-operative pregnancy
18 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Andrea Mariani, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2025-04532
Identifier Type: REGISTRY
Identifier Source: secondary_id
25-000815
Identifier Type: OTHER
Identifier Source: secondary_id
MC230601
Identifier Type: OTHER
Identifier Source: secondary_id
25-000815
Identifier Type: -
Identifier Source: org_study_id
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