Craniofacial Fibrous DysplasiaNCT07870616
Morbidity in Adults With Craniofacial Fibrous Dysplasia: The CRANIO-DF Study
An observational study of Craniofacial Fibrous Dysplasia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Fibrous dysplasia is a rare bone disorder in which normal bone is replaced by fibro-osseous tissue. Craniofacial involvement may be associated with substantial morbidity and complex multidisciplinary care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Craniofacial Fibrous Dysplasia
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2026to 1 Dec 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with fibrous dysplasia and documented craniofacial involvement recorded in the French national EasyHYBRID-DF database, including monostotic craniofacial disease and polyostotic disease involving the craniofacial skeleton.
Who may be able to join
- Age 18 years or older
- Diagnosis of fibrous dysplasia recorded in HYBRID-DF
- Craniofacial involvement recorded in HYBRID-DF
- No objection to reuse of data for research
Who cannot join
- Erroneous diagnosis of fibrous dysplasia recorded in HYBRID-DF
- Available data do not allow craniofacial involvement to be established
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
CHU de Nice
Nice, Alpes Maritimes, 06000
Marie-Charlotte TROJANI, 0492035499 ext. +33, marie-charlotte.trojani@univ-cotedazur.fr
Marie-Charlotte TROJANI, marie-charlotte.trojani@univ-cotedazur.fr
About this study
Official title: Morbidity, Management, and Outcomes in Adults With Craniofacial Fibrous Dysplasia: A National Multicenter Retrospective Study Using the EasyHYBRID-DF Database
Fibrous dysplasia is a rare bone disorder in which normal bone is replaced by fibro-osseous tissue. Craniofacial involvement may be associated with substantial morbidity and complex multidisciplinary care. CRANIO-DF aims to describe morbidity, management and outcomes in adults with craniofacial fibrous dysplasia using the French national EasyHYBRID-DF database.
Read the detailed description
CRANIO-DF is a national, multicenter, retrospective observational study based exclusively on secondary use of data already collected in HYBRID-DF. Adults with fibrous dysplasia and documented craniofacial involvement will be included. No additional data will be collected from medical records. The study will describe disease characteristics, associated manifestations, bone-targeted treatments, fractures, neurological compressions, deformities, surgical procedures, malignant transformation, endocrine events and digestive/hepatobiliary-pancreatic abnormalities when available. The primary objective is to estimate the frequency of patients with at least one documented morbid event or manifestation during follow-up. Secondary objectives are to characterize these events, describe medical and surgical management, and explore factors associated with morbidity.
- Conditions
- Craniofacial Fibrous Dysplasia
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Craniofacial Fibrous Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Craniofacial fibrous dysplasia | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of at least one documented morbid event or manifestation
Binary outcome (yes/no): presence of at least one morbid event or manifestation documented in HYBRID-DF during available follow-up, including relevant bone, neurological, surgical, malignant, endocrine or other recorded morbidity.
Measured: Up to 10 years
Secondary outcomes (3)
Nature of documented morbid events or manifestations
Nature of events/manifestations, number of events per patient, time to event when a date is available, and recurrence/progression when recorded.
Measured: Up to 10 years
Burden of documented morbid events or manifestations
Burden of events/manifestations, number of events per patient, time to event when a date is available, and recurrence/progression when recorded.
Measured: Up to 10 years
Disease management
Type and duration of bone-targeted and/or surgical treatments
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniofacial Fibrous DysplasiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870616
- Sponsor's protocol ID
- 26Rhumato01
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbidity, Management, and Outcomes in Adults With Craniofacial Fibrous Dysplasia: A National Multicenter Retrospective Study Using the EasyHYBRID-DF Database
- ClinicalTrials.gov ID
- NCT07870616
- Acronym / sponsor ID
- 26Rhumato01
- Conditions
- Craniofacial Fibrous Dysplasia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 13 Oct 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.
Fibrous dysplasia is a rare bone disorder in which normal bone is replaced by fibro-osseous tissue. Craniofacial involvement may be associated with substantial morbidity and complex multidisciplinary care. CRANIO-DF aims to describe morbidity, management and outcomes in adults with craniofacial fibrous dysplasia using the French national EasyHYBRID-DF database.
Detailed description
CRANIO-DF is a national, multicenter, retrospective observational study based exclusively on secondary use of data already collected in HYBRID-DF. Adults with fibrous dysplasia and documented craniofacial involvement will be included. No additional data will be collected from medical records. The study will describe disease characteristics, associated manifestations, bone-targeted treatments, fractures, neurological compressions, deformities, surgical procedures, malignant transformation, endocrine events and digestive/hepatobiliary-pancreatic abnormalities when available. The primary objective is to estimate the frequency of patients with at least one documented morbid event or manifestation during follow-up. Secondary objectives are to characterize these events, describe medical and surgical management, and explore factors associated with morbidity.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Craniofacial fibrous dysplasia | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with fibrous dysplasia and documented craniofacial involvement recorded in the French national EasyHYBRID-DF database, including monostotic craniofacial disease and polyostotic disease involving the craniofacial skeleton.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Diagnosis of fibrous dysplasia recorded in HYBRID-DF
- Craniofacial involvement recorded in HYBRID-DF
- No objection to reuse of data for research
Key exclusion criteria (2 listed)
- Erroneous diagnosis of fibrous dysplasia recorded in HYBRID-DF
- Available data do not allow craniofacial involvement to be established
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo Intervention | Other | Craniofacial fibrous dysplasia |
Primary outcome
Presence of at least one documented morbid event or manifestation
Time frame: Up to 10 years
Binary outcome (yes/no): presence of at least one morbid event or manifestation documented in HYBRID-DF during available follow-up, including relevant bone, neurological, surgical, malignant, endocrine or other recorded morbidity.
3 secondary outcomes
Nature of documented morbid events or manifestations
Time frame: Up to 10 years
Burden of documented morbid events or manifestations
Time frame: Up to 10 years
Disease management
Time frame: Up to 10 years
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 13 Oct 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 Craniofacial Fibrous Dysplasia, run by Centre Hospitalier Universitaire de Nice 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 2 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: opening soon, as of the sponsor's last update on 13 Oct 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 Marie-Charlotte TROJANI (0492035499 ext. +33, marie-charlotte.trojani@univ-cotedazur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of at least one documented morbid event or manifestation (time frame: Up to 10 years). 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 13 Oct 2026.