Clinical Trials in Italy / NCT06689956
Recruiting
Observational
Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: A Prospective, Multicenter, Single-Arm Observational Study
NCT06689956 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
FIGO Grade 1 Endometrial Endometrioid AdenocarcinomaFIGO Grade 2 Endometrial Endometrioid AdenocarcinomaStage IA1 Endometrial Cancer FIGO 2023Stage IA2 Endometrial Cancer FIGO 2023
Investigational drug(s) / intervention(s)
Non-Interventional Study
Non-Interventional Study: Non-Interventional Study
Study 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
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).
Primary outcome measure(s)
- Recurrence-free survival (RFS) — Up to 5 years
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.
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Houston Methodist Hospital | Houston | Texas | Recruiting |
| Medical University of Vienna | Vienna | Austria | Recruiting |
| AC Camargo Cancer Center | São Paulo | Brazil | Recruiting |
| Sunnybrook Health Sciences, University of Toronto | Toronto | Ontario | Recruiting |
| Hopital Maisonneuve Rosemont | Montreal | Quebec | Recruiting |
| Institut Universitaire du Cancer Toulouse Oncopole | Toulouse | France | Not Yet Recruiting |
| University Hospital Essen | Essen | Germany | Not Yet Recruiting |
| Meir Medical Center, Faculty of Medicine - Tel-Aviv University | Kefar Sava | Israel | Not Yet Recruiting |
| Ospedale Michele e Pietro Ferrero | Verduno | CN | Not Yet Recruiting |
| IRCCS Fondazione San Gerardo dei Tintori | Monza | MB | Not Yet Recruiting |
| Fondazione IRCCS Istituto Nazionale Tumori | Milan | MI | Recruiting |
| European Institute of Oncology | Milan | MI | Recruiting |
| Policlinico Universitario Fondazione Agostino Gemelli | Roma | RM | Recruiting |
| University of Udine | Udine | UD | Not Yet Recruiting |
| Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale | Naples | Italy | Not Yet Recruiting |
| Hospital Materno Infantil Las Palmas | Las Palmas | Spain | Recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Recruiting |
| Ospedale Regionale di Lugano, Civico | Lugano | Switzerland | Recruiting |
More Mayo Clinic trials in Italy
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06689956 on ClinicalTrials.gov ↗ ← All trials in Italy