Endometrial CarcinomaNCT07062016
Molecular and ctDNA Characterization of High-Risk Endometrial Cancer
An observational study of Endometrial Carcinoma and Endometrial High Grade Endometrioid Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Carcinoma, Endometrial High Grade Endometrioid Adenocarcinoma, Stage II Endometrial Cancer
- What is being tested?
- Non-Interventional Study
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Endometrial cancer patients with aggressive disease and planned complete surgical staging at Mayo Clinic.
Who may be able to join
- 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)
Show all 16Show fewer
- 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
Who cannot join
- Patient receiving or who has received neoadjuvant chemotherapy
- Pre-operative pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Evelyn A. Reynolds, MD
About this study
Official title: MC230601 Molecular and ctDNA Characterization of High-Risk Endometrial Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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
- Endometrial Carcinoma, Endometrial High Grade Endometrioid Adenocarcinoma, Stage II Endometrial Cancer, Stage III Endometrial Cancer, Stage IV Endometrial Cancer
- Being tested
- Non-Interventional Study
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo blood and tissue sample collection and have their medical records reviewed throughout the study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival (RFS)
Defined as time from primary staging surgery to recurrence or death.
Measured: Up to 3 years
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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Oct 2025
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evelyn A. Reynolds, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062016
- Sponsor's protocol ID
- MC230601
- Other IDs
- NCI-2025-04532, 25-000815, MC230601
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MC230601 Molecular and ctDNA Characterization of High-Risk Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07062016
- Acronym / sponsor ID
- MC230601
- Conditions
- Endometrial Carcinoma, Endometrial High Grade Endometrioid Adenocarcinoma, Stage II Endometrial Cancer, Stage III Endometrial Cancer, Stage IV Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo blood and tissue sample collection and have their medical records reviewed throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Endometrial cancer patients with aggressive disease and planned complete surgical staging at Mayo Clinic.
Key inclusion criteria (16 listed)
- 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]
- Provide written informed consent
- Willingness to provide mandatory blood specimens for correlative research
Key exclusion criteria (2 listed)
- Patient receiving or who has received neoadjuvant chemotherapy
- Pre-operative pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Recurrence-free survival (RFS)
Time frame: Up to 3 years
Defined as time from primary staging surgery to recurrence or death.
Presence of somatic and germline pathogenic variants
Time frame: Up to 3 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evelyn A. Reynolds, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Carcinoma and Endometrial High Grade Endometrioid Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (RFS) (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.