NCT06689956

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.

Trial Health

88
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach
10 countries

20 active sites

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 Progress29%
Dec 2024Oct 2029

First Submitted

Initial submission to the registry

November 13, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

December 4, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2029

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

4.9 years

First QC Date

November 13, 2024

Last Update Submit

February 17, 2026

Conditions

FIGO Grade 2 Endometrial Endometrioid AdenocarcinomaStage IA1 Endometrial Cancer FIGO 2023Stage IA2 Endometrial Cancer FIGO 2023FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free survival (RFS)

    RFS is defined as the length of time after primary treatment that the patient survives without any signs or symptoms of that cancer. (Recurrence may be vaginal, hematogenous, lymphatic, or peritoneal.) RFS will be measured from the date of surgery to the date of recurrence, death, or last disease evaluation.

    Up to 5 years

Secondary Outcomes (2)

  • Non-vaginal RFS

    Up to 5 years

  • Overall Survival (OS)

    Up to 5 years

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional StudyOTHER

Non-Interventional Study

Observational

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with low-risk endometrial cancer.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Medical University of Vienna

Vienna, Austria

RECRUITING

AC Camargo Cancer Center

São Paulo, Brazil

RECRUITING

Sunnybrook Health Sciences, University of Toronto

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Hopital Maisonneuve Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, 31100, France

NOT YET RECRUITING

University Hospital Essen

Essen, 45147, Germany

NOT YET RECRUITING

Meir Medical Center, Faculty of Medicine - Tel-Aviv University

Kefar Sava, Israel

NOT YET RECRUITING

Ospedale Michele e Pietro Ferrero

Verduno, CN, 12060, Italy

NOT YET RECRUITING

IRCCS Fondazione San Gerardo dei Tintori

Monza, MB, 20900, Italy

NOT YET RECRUITING

Fondazione IRCCS Istituto Nazionale Tumori

Milan, MI, 20133, Italy

RECRUITING

European Institute of Oncology

Milan, MI, 20141, Italy

RECRUITING

Policlinico Universitario Fondazione Agostino Gemelli

Roma, RM, 00168, Italy

RECRUITING

University of Udine

Udine, UD, 33100, Italy

NOT YET RECRUITING

Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale

Naples, 80131, Italy

NOT YET RECRUITING

Hospital Materno Infantil Las Palmas

Las Palmas, 35016, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28029, Spain

RECRUITING

Ospedale Regionale di Lugano, Civico

Lugano, 6900, Switzerland

RECRUITING

Related Publications (1)

  • De Vitis LA, Bogani G, Raspagliesi F, Arencibia Sanchez O, Navarro B, Multinu F, Zanagnolo V, Baiocchi G, De Brot L, Fanfani F, Capasso I, Piedimonte S, DeGuerke L, Buda A, Mauro J, Alessio M, Filipello F, Beiner M, Kadan Y, Papadia A, Vizzielli G, Restaino S, Grassi T, Landoni F, Bianchi T, Grimm C, Polterauer S, Ricotta G, Martinez A, Buderath P, Kimmig R, Chiantera V, Zand B, Zapardiel I, Hernandez A, Gill S, Covens A, Dagher C, Meschini T, Cucinella G, Schivardi G, Occhiali T, Lembo A, Palmieri E, Shahi M, Fought AJ, McGree ME, Suman VJ, Abu-Rustum NR, Ramirez PT, Mariani A, Glaser GE; Low Volume Metastasis in Endometrial Cancer Consortium. Outcomes of low-risk endometrial cancer with isolated tumor cells in the sentinel lymph nodes: a prospective, multi-center, single-arm, observational study (ENDO-ITC study). Int J Gynecol Cancer. 2025 Aug;35(8):101764. doi: 10.1016/j.ijgc.2025.101764. Epub 2025 Mar 7.

    PMID: 40148176DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue samples will be collected from sentinel lymph nodes (SLN) biopsy and uterine tumor removed during planned surgery that are not needed for clinical care.

Study Officials

  • Gretchen E. Glaser, 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

November 13, 2024

First Posted

November 15, 2024

Study Start

December 4, 2024

Primary Completion (Estimated)

October 31, 2029

Study Completion (Estimated)

October 31, 2029

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations

ES(2)US(3)DE(1)IT(7)CA(2)BR(1)FR(1)IL(1)AU(1)CH(1)