RecruitingNCT06689956

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

Sponsor

Mayo Clinic

Enrollment

212 participants

Start Date

Dec 4, 2024

Study Type

OBSERVATIONAL

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

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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study is following women with low-risk endometrial (uterine) cancer who were found to have isolated tumour cells in their sentinel lymph nodes during surgery — a situation where only a very small number of cancer cells were detected in nearby lymph nodes. The study aims to understand whether these patients need additional treatment or if careful monitoring is enough. **You may be eligible if...** - You have been diagnosed with low-risk endometrial cancer (endometrioid type, Grade 1 or 2, Stage IA) - You have had complete surgical staging, including sentinel lymph node biopsy - Isolated tumour cells were found in your sentinel lymph nodes - You had minimal or no blood vessel invasion in your tumour **You may NOT be eligible if...** - Your cancer is a higher grade, higher stage, or more aggressive type - You had extensive lymph vessel invasion in your tumour - You have not completed the required surgical staging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNon-Interventional Study

Non-Interventional Study

Locations(20)

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 Infantil Las Palmas

Las Palmas, Spain

Hospital Universitario La Paz

Madrid, Spain

Ospedale Regionale di Lugano, Civico

Lugano, Switzerland

View Full Details on ClinicalTrials.gov

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NCT06689956