The Value of the O-RADS Radiological Classification in Predicting the Malignancy of Ovarian Masses in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- O-RADS IRM (MRI)
研究概览
简要总结
When faced with an ovarian mass in a girl, conservative surgery (resection of the mass while preserving healthy ovarian tissue) via laparoscopy remains the most appropriate treatment option. However, this option is no longer indicated for malignant tumors, as this presents a risk of tumor dissemination that can significantly alter the child's subsequent prognosis. Therefore, for any malignant or suspected malignant tumor, radical treatment consisting of oophorectomy or salpingo-oophorectomy, often via laparotomy, is the standard. While keeping this therapeutic principle in mind, differentiating between benign and malignant entities remains the major challenge for clinicians. Furthermore, the diagnostic accuracy of the O-RADS classification based on MRI is not sufficiently established in the literature for children. Our project aims to conduct a multicenter study in the pediatric population to investigate the usefulness of this radiological classification in the preoperative diagnosis of ovarian masses.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Girls under 16 years of age.
- •Girls who underwent surgery for ovarian masses at the Pediatric Surgery Department of Mohammed VI University Hospital in Oujda during the study period.
- •Girls who underwent surgery for ovarian masses at the Pediatric Surgery Department of Strasbourg University Hospital during the study period.
- •Girls who underwent preoperative MRI.
排除标准
- •Girls who underwent preoperative MRI.
- •Patients who did not undergo surgery.
- •Patients without histopathological examination of the surgical specimen.
- •Patients without MRI as a preoperative diagnostic evaluation modality.
结局指标
主要结局
O-RADS IRM (MRI)
时间窗: Up to 9 months
Score Interpretation Risk O-RADS MRI 1 Normal 0% O-RADS MRI 2 Benign \< 1% O-RADS MRI 3 Probably Benign \~5% O-RADS MRI 4 Suspicious \~50% O-RADS MRI 5 Highly Suspicious \> 90%
次要结局
未报告次要终点
