Recruiting

Genetic Variants

Sponsor:

Mayo Clinic

Code:

NCT07062016

Conditions

Endometrial Carcinoma

Endometrial High Grade Endometrioid Adenocarcinoma

Stage II Endometrial Cancer

Stage III Endometrial Cancer

Stage IV Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

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.

Conditions

Endometrial Carcinoma

Endometrial High Grade Endometrioid Adenocarcinoma

Stage II Endometrial Cancer

Stage III Endometrial Cancer

Stage IV Endometrial Cancer

Study ID

NCT07062016

Start date

Oct 1, 2025

Status verified date

Apr, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not 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 pregnancy

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

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

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Recurrence-free survival (RFS) [ Time Frame: Up to 3 years ]
  • Presence of somatic and germline pathogenic variants [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Evelyn A. Reynolds, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-13.