The Fibrodysplasia Ossificans Progressiva (FOP) Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorThe International FOP Association
About this trial
The Fibrodysplasia Ossificans Progressiva (FOP) Registry is a global, non-interventional, voluntary database that captures demographic and disease data directly from FOP patients and their caregivers via a secure, web-based patient portal. A physician portal (in development) will allow physicians to enter clinical data about their patients. The objectives are to organize the international FOP community for participation in clinical trials; to enable FOP patients worldwide to report data in a shared forum; to improve the collective understanding of FOP natural history; and to advance the understanding of FOP treatment outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have a confirmed diagnosis of FOP.
Participants (or a parent or legal guardian) must be willing and able to provide written informed consent.
Disqualifiers
There are no exclusion criteria.
Trial population
Individuals with Fibrodysplasia Ossificans Progressive (FOP) from the international FOP community will be invited to join the Registry.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
800 Participants
are grouped into 1 trial groupGroup A: FOP Patients
Trial outcomes
Primary outcomes
1
Patient Reported Changes in New Bone Growth Using a Patient-Directed Survey Developed by the IFOPA
The patient is able to report changes in new bone growth among 27 joints and body locations.
Time frame
Baseline, then every six months for up to 10 years2
Patient Reported Changes in Episodic Flare-Ups Using a Patient-Directed Survey Developed by the IFOPA
The patient is able to report changes in episodic flare-ups among 27 joints and body locations.
Time frame
Baseline, then every six months for up to 10 years3
Patient Reported Changes in Mobility Using a Patient-Directed Survey Developed by the IFOPA
The patient is able to report changes in mobility among 27 joints and body locations.
Time frame
Baseline, then every six months for up to 10 yearsSecondary outcomes
1
Patient Reported Changes in Health Resource Utilization Using a Patient-Directed Survey Developed by the IFOPA
The number of visits to a Physician and a Dentist, as well as the number of hospitalizations and reasons for the hospitalizations, are used to assess health resource utilization.
Time frame
Baseline, then every six months for up to 10 years2
Patient Reported Changes in Signs Related to the Ear Using a Patient-Directed Survey Developed by the IFOPA
The patient is able to report new or continuing health issues related to the ears.
Time frame
Baseline, then every six months for up to 10 years3
Patient Reported Changes in Signs Related to the Skin Using a Patient-Directed Survey Developed by the IFOPA
The patient is able to report new or continuing health issues related to the skin.
Time frame
Baseline, then every six months for up to 10 years4
Patient Reported Changes in Signs Related to the Central Nervous System Using a Patient-Directed Survey Developed by the IFOPA
The patient is able to report new or continuing health issues related to the central nervous system.
Time frame
Baseline, then every six months for up to 10 yearsOther outcomes
1
Patient Reported Changes in Activities of Daily Living Using the FOP-Physical Functioning Questionnaire (PFQ)
Time frame
Baseline, then every six months for up to 10 years2
Patient Reported Changes in Overall Health Using the PROMIS Global Health Scale
Time frame
Baseline, then every six months for up to 10 years3
Patient Reported Changes in the Need for Assistive Devices, Aids, Attendants, and Adaptations Using a Survey Developed by the IFOPA
The patient is able to respond Yes or No to questions related to his/her need for Assistive Devices, Aids, Attendants, and Adaptations as a result of his/her FOP disease.
Time frame
Baseline, then every six months for up to 10 yearsSponsors and contacts
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Source ClinicalTrials.gov