Molecular and ctDNA Characterization of High-Risk Endometrial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry conditions: Endometrial Carcinoma, Endometrial High Grade Endometrioid Adenocarcinoma, Stage II Endometrial Cancer, Stage III Endometrial Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MC230601 Molecular and ctDNA Characterization of High-Risk Endometrial Cancer
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.
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.
Interventions
- Other Non-Interventional Study
Non-interventional study
Primary outcome measures
- Recurrence-free survival (RFS) [Time frame: Up to 3 years]
- Presence of somatic and germline pathogenic variants [Time frame: Up to 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07062016 · MC230601 · NCI-2025-04532 · 25-000815 · MC230601