Clinical trial NCT06689956: Outcomes of Low-Risk Endometrial Cancer with Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective, Multicenter, Cohort Study
Official title: Outcomes of Low-Risk Endometrial Cancer with Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective Multicenter Single-Arm Observational Study
Study type: OBSERVATIONAL
Overall 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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 212
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with low-risk endometrial cancer.

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.

Detailed description: PRIMARY OBJECTIVE:

I. Evaluate whether patients with low-risk endometrial cancer and isolated tumor cells (ITC) will have worse recurrence-free survival (RFS) than a historical cohort of similar patients with negative nodes.

OUTLINE: This is an observational study.

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

Eligibility criteria: 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) identified in SLN.
  * Willingness to forego adjuvant treatment.
  * Research consent provided.

Exclusion Criteria:

* Prior neoadjuvant chemotherapy.

  * Planning to receiving adjuvant treatment.
  * Presence of synchronous 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.
  * No prior invasive cancer diagnosis within 5 years of study entry.

Primary outcomes:
measure: Recurrence-free survival (RFS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Non-vaginal RFS
timeFrame: Up to 5 years
measure: Overall Survival (OS)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Vienna
country: Austria
facility: Medical University of Vienna
city: São Paulo
country: Brazil
facility: AC Camargo Cancer Center
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences, University of Toronto
state: Ontario
city: Montréal
country: Canada
facility: Hopital Maisonneuve Rosemont
state: Quebec
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse Oncopole
city: Essen
country: Germany
facility: University Hospital Essen
city: Kefar Sava
country: Israel
facility: Meir Medical Center, Faculty of Medicine - Tel-Aviv University
city: Verduno
country: Italy
facility: Ospedale Michele e Pietro Ferrero
state: CN
city: Monza
country: Italy
facility: IRCCS Fondazione San Gerardo dei Tintori
state: MB
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori
state: MI
city: Milano
country: Italy
facility: European Institute of Oncology
state: MI
city: Roma
country: Italy
facility: Policlinico Universitario Fondazione Agostino Gemelli
state: RM
city: Udine
country: Italy
facility: University of Udine
state: UD
city: Naples
country: Italy
facility: Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
city: Las Palmas
country: Spain
facility: Hospital Materno of Las Palmas
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano, Civico
Study officials:
affiliation: Mayo Clinic in Rochester
name: Gretchen E. Glaser, MD
role: PRINCIPAL_INVESTIGATOR
References: