Ovarian; MastopathyMMONCT07313514
The Value of the O-RADS Radiological Classification in Predicting the Malignancy of Ovarian Masses in Children
An observational study of Ovarian; Mastopathy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Ovarian; Mastopathy
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Girls under 16 years of age who underwent surgery for ovarian masses at the Pediatric Surgery Department
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Pédiatrique - CHU de Strasbourg - France
Strasbourg, 67091
Isabelle TALON, MD, PhD, 33 3 88 12 72 96, Isabelle.TALON@chru-strasbourg.fr
Isabelle TALON, MD, PhD
About this study
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.
- Conditions
- Ovarian; Mastopathy
- Keywords
- Malignancy in Ovarian Masses, Ovarian; Mastopathy
- Medical subject headings
- Breast Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start11 Mar 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian; MastopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313514
- Sponsor's protocol ID
- 9613
- Acronym
- MMO
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of the O-RADS Radiological Classification in Predicting the Malignancy of Ovarian Masses in Children
- ClinicalTrials.gov ID
- NCT07313514
- Acronym / sponsor ID
- MMO / 9613
- Conditions
- Ovarian; Mastopathy
- Keywords
- Malignancy in Ovarian Masses, Ovarian; Mastopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Girls under 16 years of age who underwent surgery for ovarian masses at the Pediatric Surgery Department
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
O-RADS IRM (MRI)
Time frame: 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%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian; Mastopathy, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle TALON, MD, PhD (33 3 88 12 72 96, Isabelle.TALON@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
O-RADS IRM (MRI) (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.