Evaluation of Agreement in Histological Findings Between Core Needle and Incisional Biopsies
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- compare the agreement between core needle biopsy and incisional biopsy, based on Cohen's kappa coefficient.
研究概览
简要总结
The investigators will collect data of patients with high suspicion of malignant bone tumor based on radiological imaging who underwent/will undergo both core needle biopsy and incisional biopsy for diagnostic confirmation by histological examination.
From 01/01/2015 to the approval date of this study: retrospective study; from the approval date of this study to 31/12/2027: prospective study. the investigators expect to collect data from a total of 72 patients: approximately 30 patients for the retrospective study and 42 for the prospective study. A review will be made from the medical records, radiological imaging, and histological data of partecipants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 2 years
- •Patients with high suspicion of malignant bone tumor who underwent/will undergo both core needle biopsy and incisional biopsy
- •Male and female patients treated at Rizzoli Orthopaedic Institute from the approval date of this study to 31/12/2027
- •Patients with available clinical and imaging data
排除标准
- •Patients with bone tumor who underwent/will undergo only core needle biopsy
- •Patients with bone tumor who underwent/ will undergo only incisional biopsy
结局指标
主要结局
compare the agreement between core needle biopsy and incisional biopsy, based on Cohen's kappa coefficient.
时间窗: through study completion, an average of 3 year
次要结局
未报告次要终点