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

Recruiting now

Conditions studied: Ovarian; Mastopathy

In brief

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.

Key facts

Study ID

NCT07313514

Run by

University Hospital, Strasbourg, France

People needed

100

Starts

2025-03-11

Expected to finish

2026-02-01

Last updated by the study team

2026-01-02

Who can join

Age: 1 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Service de Chirurgie Pédiatrique - CHU de Strasbourg - France — Strasbourg, France (enrolling)

Full record on ClinicalTrials.gov

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