跳至主要内容
临床试验/NCT07313514
NCT07313514招募中不适用

The Value of the O-RADS Radiological Classification in Predicting the Malignancy of Ovarian Masses in Children

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月11日最近更新:
适应症

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

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

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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