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Recruiting Observational

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

NCT07313514 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-03-11
Last updated
2026-01-02

Condition(s) studied

Ovarian; Mastopathy

Study summary

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.

Eligibility

Sex
ALL
Min age
1 Year
Max age
16 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • O-RADS IRM (MRI) — 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%

Trial sites (1)

FacilityCityRegionStatus
Service de Chirurgie Pédiatrique - CHU de Strasbourg - France Strasbourg France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07313514 on ClinicalTrials.gov ↗ ← All trials in France