One Step Nucleic Acid Amplification (OSNA) Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer: a Randomized, Multicenter, Controlled Trial (SENT-OSNA Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,922
- 试验地点
- 1
- 主要终点
- Number of SLN metastasis detected by OSNA versus ultrastaging method
研究概览
简要总结
Patients enrolled in the study will be randomized before surgery: in one study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard), while in the other arm it will be conducted using the OSNA method.
详细描述
This is a non-inferiority randomized trial with the incidence of patients with metastatic SLN as primary endpoint. Based on recent literature, incidence of patients with metastatic SLN detected by ultrastaging has an average value of 11%. Assuming a -4% as the maximum allowable difference in detection rate to declare non-inferiority, a power of 80% and a significance level of 2.5% (one-side) a sample size of 1922 (961 per arm) is needed. Two interim analyses are planned, one after the first 640 and the second after 1280 patients. At the first interim analysis null hypothesis (inferiority of OSNA with respect to ultrastaging) will be rejected at a significance level <0.00010 otherwise the study will go on and at the second analysis the null hypothesis will be rejected at a significance level of 0.0059. The final analysis will use 0.0189 as significance threshold. The O'Brien Fleming alpha spending function was used to define these values.
The primary endpoint is defined as the proportion of patients with positive SLN over the total of randomized patients. This proportion will be reported together with the 95% confidence interval to better identify the range of inferential values. Incidence of isolated tumor cells, micro- and macro-metastasis will be calculated.
Number of copies of CK19 mRNA to define volume of metastases will be adapted from previous reports.
To describe the sample, quantitative variables will be summarized using median and interquartile range while categorical items will be reported as absolute counts and percentages. Patients will be described according the arm they were randomized to. A first analysis will be performed on an Intent-To-Treat basis, considering all randomized patients. A secondary analysis will be performed on the Per-Protocol population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed endometrial cancer
- •Apparent (pre-operative) FIGO stage I-II
- •Radical surgery
- •Attempt of SLN mapping
排除标准
- •Uterine sarcoma (including endometrial stromal sarcoma)
- •Fertility sparing surgery
- •Dedifferentiated histology
- •Undifferentiated histology
- •Neoadjuvant therapy
- •Previous surgery to pelvic lymph nodes
- •Lymph nodes with short axis >15 mm at pre-operative imaging
研究组 & 干预措施
ultrastaging arm
In this study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard)
干预措施: Ultrastaging (Device)
OSNA arm
In this arm the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the OSNA method (experimental)
干预措施: OSNA (Device)
结局指标
主要结局
Number of SLN metastasis detected by OSNA versus ultrastaging method
时间窗: From enrollment to the acquisition of the histological examination (8 weeks)
We will evaluate the number of lymph node metastases identified with both methods, in order to calculate the incidence of lymph node metastases for each group
次要结局
- Overall survival (measured in months) in patients with a diagnosis of lymph node metastases (identified with OSNA and ultrastaging), performing stratification by molecular class.(3 years (a 3-year follow-up is planned))
- Disease-free survival (measured in months) in patients with a diagnosis of lymph node metastases (identified with OSNA and ultrastaging), performing stratification by molecular class.(3 years (a 3-year follow-up is planned))
- 3 year disease-free survival (measured in months) in OSNA versus ultrastaging negative patients(3 years (a 3-year follow-up is planned))
- 3 year overall survival (measured in months) in OSNA versus ultrastaging negative patients(3 years (a 3-year follow-up is planned))
- 5-year disease-free survival (measured in months) in OSNA versus ultrastaging negative patients(5 years)
- 5-year overall survival (measured in months) in OSNA versus ultrastaging negative patients(5 years)
- Incidence of endosalpingiosis in ultrastaging arm(From enrollment to the acquisition of the histological examination (8 weeks))
- Total Tumor Load (calculating by summing the number of copies of CK19 from each sentinel lymph node) and correlation with prognosis(3 years (a 3-year follow-up is planned))
- Dimension of SLN (measured in millimeters) metastases at ultrastaging and correlation with prognosis(3 years (a 3-year follow-up is planned))
研究者
Fanfani Francesco
Professor Francesco Fanfani
Fondazione Policlinico Universitario Agostino Gemelli IRCCS