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Not yet recruitingNCT07870616Updated Oct 13, 2026

Morbidity in Adults With Craniofacial Fibrous Dysplasia: The CRANIO-DF Study

An observational study in Craniofacial Fibrous Dysplasia, sponsored by Centre Hospitalier Universitaire de Nice. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Centre Hospitalier Universitaire de Nice · Observational

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
500
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Craniofacial Fibrous Dysplasia
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In context

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 722 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Erroneous diagnosis of fibrous dysplasia recorded in HYBRID-DF
  • Available data do not allow craniofacial involvement to be established
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Craniofacial fibrous dysplasia

    Other: No Intervention: Observational Cohort

Interventions

  • OtherNo Intervention: Observational Cohort

    No Intervention

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 10 years

Secondary outcomes

  1. 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.

    Time frame: Up to 10 years

  2. 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.

    Time frame: Up to 10 years

  3. Disease management

    Type and duration of bone-targeted and/or surgical treatments

    Time frame: Up to 10 years

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Study locations

1 site
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Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07870616
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Nov 30, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

Marie-Charlotte TROJANI
Contact
marie-charlotte.trojani@univ-cotedazur.fr
0492035499 ext. +33

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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