An observational study in Ovarian; Mastopathy, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by University Hospital, Strasbourg, France · Observational
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.
149 studies on the registry are indexed under Breast Diseases; 25 are open to participants now.
This study's planned enrollment of 100 is below the median of 225 across 55 observational studies indexed under Breast Diseases.
Browse Breast Diseases studies →University Hospital, Strasbourg, France is the lead sponsor of 968 studies on the registry; 344 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Girls under 16 years of age who underwent surgery for ovarian masses at the Pediatric Surgery Department
Exclusion Criteria:
O-RADS IRM (MRI)
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%
Time frame: Up to 9 months
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University Hospital, Strasbourg, France