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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Erroneous diagnosis of fibrous dysplasia recorded in HYBRID-DF

Available data do not allow craniofacial involvement to be established

Trial 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.

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • No Intervention: Observational Cohort

    Other intervention

    No Intervention

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Craniofacial fibrous dysplasia1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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