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RecruitingNCT07313514MMOUpdated Jan 2, 2026

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

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

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
100
Ages
1 Year to 16 Years
Sex
All
01

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.

02

Conditions studied

  • Ovarian; Mastopathy

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Keywords

  • Malignancy in Ovarian Masses
  • Ovarian; Mastopathy
03

In context

Breast Diseases

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Girls under 16 years of age who underwent surgery for ovarian masses at the Pediatric Surgery Department

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

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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Service de Chirurgie Pédiatrique - CHU de Strasbourg - France
    Strasbourg, 67091, France
    • Isabelle TALON, MD, PhD · Contact · Isabelle.TALON@chru-strasbourg.fr · 33 3 88 12 72 96
    • Isabelle TALON, MD, PhD · Principal investigator
    • Shaima AL SUDAIRI, MD · Principal investigator
    • Houssain BENHADDOU, MD, PhD · Principal investigator
    • Kamal EL HAISSOUFI, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07313514
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Jan 2, 2026
Start date
Mar 11, 2025
Primary completion
Feb 2026 (estimated)
Completion
Feb 2026 (estimated)
Last update
Jan 2, 2026

Study contacts

Isabelle TALON, MD, PhD
Contact
Isabelle.TALON@chru-strasbourg.fr
33 3 88 12 72 96

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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