Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06689956

Conditions

FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma

FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma

Stage IA1 Endometrial Cancer FIGO 2023

Stage IA2 Endometrial Cancer FIGO 2023

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

This study evaluates whether isolated tumor cells in the first lymph nodes near the tumor can tell researchers something important about the future of patients with a certain type of endometrial (uterine) cancer.

Conditions

FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma

FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma

Stage IA1 Endometrial Cancer FIGO 2023

Stage IA2 Endometrial Cancer FIGO 2023

Study ID

NCT06689956

Start date

Dec 4, 2024

Status verified date

Feb, 2026

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Oct 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Low-risk endometrial cancer, defined as endometrioid, grade 1 or 2, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA (FIGO 2023 stages IA1 and IA2), without substantial/extensive LVSI (≥ 5 vessels involved) at final pathology. Patients with focal LVSI (< 5 vessels involved) will be included.

  • Complete surgical staging, including pelvic sentinel lymph node (SLN) biopsy per National Comprehensive Cancer Network (NCCN) guidelines and ultrastaging.
  • Extent of disease in SLN: ITC (defined as tumor cell aggregates ≤ 0.2 mm or < 200 cells)
  • No adjuvant treatment after surgery
  • Research consent provided.

Exclusion Criteria:

  • Prior neoadjuvant chemotherapy.

  • Planning to receive adjuvant treatment.
  • Presence of synchronous cancer (excluding non-melanoma skin cancer).
  • Extent of disease in SLN: micrometastasis (> 0.2 to ≤ 2.0 mm) or macrometastasis (> 2.0 mm).
  • Presence of substantial/extensive LVSI (≥ 5 vessels involved) at final pathology.
  • Prior invasive cancer diagnosis within 5 years of study entry (excluding non-melanoma skin cancer).

Study Design

Enrollment

212 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients undergo tissue sample collection and have their medical records reviewed on study.

Interventions

Non-Interventional Study

Non-Interventional Study

Primary outcome measure

  • Recurrence-free survival (RFS) [ Time Frame: Up to 5 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:

Gretchen E. Glaser, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Christian Dagher

347-798-9213dagherc@mskcc.org

Principal Investigator:

Nadeem R. Abu-Rustum, MD

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Behrouz Zand

713-790-3311bzand@houstonmethodist.org

Principal Investigator:

Pedro T. Ramirez, MD

Sunnybrook Health Sciences, University of Toronto

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Stephanie Gill

+1 416-480-6100zdis-stephanie.gill@uhn.ca

Principal Investigator:

Allan Covens, MD

Hopital Maisonneuve Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Lara DeGuerke

+1 514-252-3400lara.deguerke@gmail.com

Principal Investigator:

Sabrina Piedimonte, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-19.