About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial population
Patients diagnosed with low-risk endometrial cancer.
Trial design
Cohort
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-Interventional Study
Treatment groups
Trial outcomes
Primary outcomes
Recurrence-free survival (RFS)
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.
Secondary outcomes
Non-vaginal RFS
Non-vaginal RFS is defined as the interval from the date of surgery to the date of the first of the following events: non-vaginal recurrence or death due to any cause.
Overall Survival (OS)
Overall survival is defined as the time from surgery to death due to any cause.
Sponsors and contacts
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