Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: A Prospective, Multicenter, Single-Arm Observational Study
NCT ID: NCT06689956
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
212 participants
OBSERVATIONAL
2024-12-04
2029-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational
Patients undergo tissue sample collection and have their medical records reviewed on study.
Non-Interventional Study
Non-Interventional Study
Interventions
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Non-Interventional Study
Non-Interventional Study
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Gretchen E. Glaser, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Houston Methodist Hospital
Houston, Texas, United States
Medical University of Vienna
Vienna, , Austria
AC Camargo Cancer Center
São Paulo, , Brazil
Sunnybrook Health Sciences, University of Toronto
Toronto, Ontario, Canada
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, , France
University Hospital Essen
Essen, , Germany
Meir Medical Center, Faculty of Medicine - Tel-Aviv University
Kefar Sava, , Israel
Ospedale Michele e Pietro Ferrero
Verduno, CN, Italy
IRCCS Fondazione San Gerardo dei Tintori
Monza, MB, Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milan, MI, Italy
European Institute of Oncology
Milan, MI, Italy
Policlinico Universitario Fondazione Agostino Gemelli
Roma, RM, Italy
University of Udine
Udine, UD, Italy
Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
Naples, , Italy
Hospital Materno of Las Palmas
Las Palmas, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Ospedale Regionale di Lugano, Civico
Lugano, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2024-09016
Identifier Type: REGISTRY
Identifier Source: secondary_id
23-008963
Identifier Type: OTHER
Identifier Source: secondary_id
23-008963
Identifier Type: -
Identifier Source: org_study_id
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