Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: A Prospective, Multicenter, Single-Arm Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry 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. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Brazil, Canada, France +5
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective Multicenter Single-Arm Observational Study
Overview
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.
Interventions
- Other Non-Interventional Study
Non-Interventional Study
Primary outcome measures
- Recurrence-free survival (RFS) [Time frame: Up to 5 years]
Secondary outcome measures (2)
- Non-vaginal RFS [Time frame: Up to 5 years]
- Overall Survival (OS) [Time frame: Up to 5 years]
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)
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 7 centers
- Ospedale Michele e Pietro Ferrero — Verduno
- IRCCS Fondazione San Gerardo dei Tintori — Monza
- Fondazione IRCCS Istituto Nazionale Tumori — Milan
- European Institute of Oncology — Milan
- Policlinico Universitario Fondazione Agostino Gemelli — Roma
- University of Udine — Udine
- Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale — Naples
United States · 3 centers
- Mayo Clinic in Rochester — Rochester
- Memorial Sloan Kettering Cancer Center — New York
- Houston Methodist Hospital — Houston
Canada · 2 centers
- Sunnybrook Health Sciences, University of Toronto — Toronto
- Hopital Maisonneuve Rosemont — Montreal
Spain · 2 centers
- Hospital Materno Infantil Las Palmas — Las Palmas
- Hospital Universitario La Paz — Madrid
Austria · 1 center
- Medical University of Vienna — Vienna
Brazil · 1 center
- AC Camargo Cancer Center — São Paulo
France · 1 center
- Institut Universitaire du Cancer Toulouse Oncopole — Toulouse
Germany · 1 center
- University Hospital Essen — Essen
Israel · 1 center
- Meir Medical Center, Faculty of Medicine - Tel-Aviv University — Kefar Sava
Switzerland · 1 center
- Ospedale Regionale di Lugano, Civico — Lugano
Publications
- 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, Herna PMID 40148176
Identifiers
NCT: NCT06689956 · 23-008963 · NCI-2024-09016 · 23-008963