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

NCT ID: NCT07313514

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-11

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian; Mastopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Chirurgie Pédiatrique - CHU de Strasbourg - France

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Isabelle TALON, MD, PhD

Role: CONTACT

33 3 88 12 72 96

Facility Contacts

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Isabelle TALON, MD, PhD

Role: primary

33 3 88 12 72 96

Other Identifiers

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9613

Identifier Type: -

Identifier Source: org_study_id

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