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NCT06689956Recruiting

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

Mayo Clinic

Start Date

12/4/2024

Completion Date

10/31/2029

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.

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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).

Interventions

OTHER

Non-Interventional Study

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Conditions

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

Locations

Mayo Clinic in Rochester

Rochester, Minnesota 55905

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

Medical University of Vienna

Vienna,

Austria

AC Camargo Cancer Center

São Paulo,

Brazil

Sunnybrook Health Sciences, University of Toronto

Toronto, Ontario M4N 3M5

Canada

Hopital Maisonneuve Rosemont

Montreal, Quebec H1T 2M4

Canada

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, 31100

France

University Hospital Essen

Essen, 45147

Germany

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

Kefar Sava,

Israel

Ospedale Michele e Pietro Ferrero

Verduno, CN 12060

Italy

IRCCS Fondazione San Gerardo dei Tintori

Monza, MB 20900

Italy

Fondazione IRCCS Istituto Nazionale Tumori

Milan, MI 20133

Italy

European Institute of Oncology

Milan, MI 20141

Italy

Policlinico Universitario Fondazione Agostino Gemelli

Roma, RM 00168

Italy

University of Udine

Udine, UD 33100

Italy

Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale

Naples, 80131

Italy

Hospital Materno Infantil Las Palmas

Las Palmas, 35016

Spain

Hospital Universitario La Paz

Madrid, 28029

Spain

Ospedale Regionale di Lugano, Civico

Lugano, 6900

Switzerland