NCT07062016

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
31mo left

Started Oct 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Oct 2025Oct 2028

First Submitted

Initial submission to the registry

July 2, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

July 2, 2025

Last Update Submit

April 9, 2026

Conditions

Endometrial High Grade Endometrioid AdenocarcinomaEndometrial CarcinomaStage II Endometrial CancerStage III Endometrial CancerStage IV Endometrial Cancer

Outcome Measures

Primary Outcomes (2)

  • Recurrence-free survival (RFS)

    Defined as time from primary staging surgery to recurrence or death.

    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.

    Up to 3 years

Study Arms (1)

Observational

Patients undergo blood and tissue sample collection and have their medical records reviewed throughout the study.

Other: Non-Interventional Study

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Observational

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Endometrial cancer patients with aggressive disease and planned complete surgical staging at Mayo Clinic.

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • Patient receiving or who has received neoadjuvant chemotherapy
  • Pre-operative pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Evelyn A. Reynolds, MD

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015mayocliniccancerstudies@mayo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 14, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

October 31, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)