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NCT07313514Recruiting

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

Source: ClinicalTrials.gov · Last updated 2 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
17 Dec 2025
Start date
11 Mar 2025
Primary completion date
Feb 2026
Lead sponsor
University Hospital, Strasbourg, France
NCT number
NCT07313514

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 11 Mar 2025 to the primary completion date, Feb 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who did not undergo surgery.
  • Patients without histopathological examination of the surgical specimen.

Other

  • Girls who underwent preoperative MRI.
  • Patients without MRI as a preoperative diagnostic evaluation modality.

Who the study is looking for

  • 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.

Age in the registry: 1 year to 16 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Service de Chirurgie Pédiatrique - CHU de Strasbourg - France
Coordinator of this site? Confirm its status
StrasbourgFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.