Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective Multicenter Single-Arm Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 212
- 试验地点
- 38
- 主要终点
- Recurrence-free survival (RFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Observational
Patients undergo tissue sample collection and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Recurrence-free survival (RFS)
时间窗: 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.
次要结局
- Non-vaginal RFS(Up to 5 years)
- Overall Survival (OS)(Up to 5 years)