Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: A Prospective, Multicenter, Single-Arm Observational Study

Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective Multicenter Single-Arm Observational Study

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.

Study Overview

• Status: Recruiting
• 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
• Intervention / Treatment: Other: Non-Interventional Study

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate whether the likelihood of disease recurrence differs between a prospective cohort of patients with low-risk endometrial cancer with ITC and an historical cohort with negative SLNs.

OUTLINE: This is an observational study.

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

• Study Type: Observational
• Enrollment (Estimated): 212

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • Medical University of Vienna
    • Principal Investigator: Christoph Grimm, MD
    • Contact: Stephan Polterauer; Phone Number: +43 1 401600; Email: stephan.polterauer@meduniwien.ac.at
• Brazil
  • São Paulo, Brazil
    • Recruiting
    • AC Camargo Cancer Center
    • Contact: Louise De Brot; Phone Number: +55 11 2189-5000; Email: louise.andrade@accamargo.org.br
    • Principal Investigator: Glauco Baiocchi, MD, PhD
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences, University of Toronto
      • Contact: Stephanie Gill; Phone Number: +1 416-480-6100; Email: zdis-stephanie.gill@uhn.ca
      • Principal Investigator: Allan Covens, MD
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Recruiting
      • Hopital Maisonneuve Rosemont
      • Contact: Lara DeGuerke; Phone Number: +1 514-252-3400; Email: lara.deguerke@gmail.com
      • Principal Investigator: Sabrina Piedimonte, MD
• France
  • Toulouse, France, 31100
    • Not yet recruiting
    • Institut Universitaire du Cancer Toulouse Oncopole
    • Contact: Alejandra Martinez; Phone Number: +33 5 31 15 50 50; Email: martinez.alejandra@iuct-oncopole.fr
    • Principal Investigator: Giulio Ricotta, MD
• Germany
  • Essen, Germany, 45147
    • Not yet recruiting
    • University Hospital Essen
    • Contact: Rainer Kimmig; Phone Number: +49 201 7230; Email: Rainer.Kimmig@uk-essen.de
    • Principal Investigator: Paul Buderath, MD
• Israel
  • Kefar Sava, Israel
    • Not yet recruiting
    • Meir Medical Center, Faculty of Medicine - Tel-Aviv University
    • Contact: Yfat Kadan; Phone Number: +972 9-747-2555; Email: yfat_ka@clalit.org.il
    • Principal Investigator: Mario Beiner, MD
• Italy
  • Naples, Italy, 80131
    • Not yet recruiting
    • Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
    • Contact: Giuseppe Cucinella; Phone Number: +39 081 590 3111; Email: giuseppecucinella@outlook.com
    • Principal Investigator: Vito Chiantera, MD
  • CN
    • Verduno, CN, Italy, 12060
      • Not yet recruiting
      • Ospedale Michele e Pietro Ferrero
      • Contact: Jessica Mauro; Phone Number: +39 0173 316111; Email: jmauro@aslcn2.it
      • Principal Investigator: Alessandro Buda, MD
  • MB
    • Monza, MB, Italy, 20900
      • Not yet recruiting
      • IRCCS Fondazione San Gerardo dei Tintori
      • Contact: Tommaso Grassi; Phone Number: +39 2331; Email: grassi.tommaso88@gmail.com
      • Principal Investigator: Fabio Landon, MD
  • MI
    • Milan, MI, Italy, 20141
      • Recruiting
      • European Institute of Oncology
      • Contact: Gabriella Schivardi; Phone Number: +39 02 574891; Email: gabriella.schivardi@ieo.it
      • Principal Investigator: Francesco Multinu, MD
    • Milan, MI, Italy, 20133
      • Recruiting
      • Fondazione IRCCS Istituto Nazionale Tumori
      • Contact: Giorgio Bogani; Phone Number: +39 02 23901; Email: giorgio.bogani@istitutotumori.mi.it
      • Principal Investigator: Francesco Raspagliesi, MD
  • RM
    • Roma, RM, Italy, 00168
      • Recruiting
      • Policlinico Universitario Fondazione Agostino Gemelli
      • Contact: Ilaria Capasso; Phone Number: +39 06 30151; Email: capasso.ilaria@mayo.edu
      • Principal Investigator: Francesco Fanfani, MD
  • UD
    • Udine, UD, Italy, 33100
      • Not yet recruiting
      • University of Udine
      • Contact: Tommaso Occhiali; Phone Number: +39 0432 556111; Email: tommaso.occhiali@gmail.com
      • Principal Investigator: Giuseppe Vizzielli, MD, PhD
• Spain
  • Las Palmas, Spain, 35016
    • Recruiting
    • Hospital Materno Infantil Las Palmas
    • Contact: Beatriz Navarro; Phone Number: +34 928 44 45 00; Email: bea_0904@hotmail.com
    • Principal Investigator: Octavio Arencibia Sanchez, MD, PhD
  • Madrid, Spain, 28029
    • Recruiting
    • Hospital Universitario La Paz
    • Contact: Alicia Hernandez; Phone Number: +34 917 27 75 76; Email: aliciahernandezg@gmail.com
    • Principal Investigator: Ignacio Zapardiel, MD
• Switzerland
  • Lugano, Switzerland, 6900
    • Recruiting
    • Ospedale Regionale di Lugano, Civico
    • Contact: Andrea Papadia, MD, PhD; Phone Number: 091 811 61 58; Email: andrea.papadia@eoc.ch
    • Principal Investigator: Andrea Papadia, MD, PhD
• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Gretchen E. Glaser, MD
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Christian Dagher; Phone Number: 347-798-9213; Email: dagherc@mskcc.org
      • Principal Investigator: Nadeem R. Abu-Rustum, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Contact: Behrouz Zand; Phone Number: 713-790-3311; Email: bzand@houstonmethodist.org
      • Principal Investigator: Pedro T. Ramirez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with low-risk endometrial cancer.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Patients undergo tissue sample collection and have their medical records reviewed on study.	Other: Non-Interventional Study; Non-Interventional Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-vaginal RFS	Non-vaginal RFS is defined as the interval from the date of surgery to the date of the first of the following events: non-vaginal recurrence or death due to any cause.	Up to 5 years
Overall Survival (OS)	Overall survival is defined as the time from surgery to death due to any cause.	Up to 5 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Gretchen E. Glaser, MD, Mayo Clinic in Rochester

Publications and helpful links

General Publications

• 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.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2029

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Uterine Diseases; Genital Diseases, Female; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Uterine Neoplasms; Ovarian Neoplasms; Adenocarcinoma; Endometrial Neoplasms; Carcinoma, Endometrioid
• Other Study ID Numbers: 23-008963 (Other Identifier: Mayo Clinic in Rochester); NCI-2024-09016 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No