The Fibrodysplasia Ossificans Progressiva (FOP) Connection Registry
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2015 |
| End Date: | December 2025 |
| Contact: | Neal S Mantick, BS, MS |
| Email: | registry@fopconnection.org |
| Phone: | 1-617-910-8508 |
FOP Connection: A Global Registry for the Fibrodysplasia Ossificans Progressiva Community
The Fibrodysplasia Ossificans Progressiva (FOP) Connection 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.
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.
The FOP Connection 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. No experimental intervention is involved. 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.
The Registry collects data through two sources. First, the Patient Portal (launched in July
2015) allows FOP patients and caregivers to enter information about their experiences living
with FOP. Second, the Physician Portal (in development) will allow physicians to enter
clinical data about patients under their care. The Registry will be capable of including
data on specific marketed therapies under the direction and control of a sponsoring
pharmaceutical company. Key identifiers will link the physician-reported data with the
Patient Portal data.
Participants must have a confirmed diagnosis of FOP and the participant (or a parent or
legal guardian) must be willing and able to provide written informed consent. There are no
exclusion criteria. Data collected in the Patient Portal include: patient demographics and
diagnosis pathway; medical and dental care; clinical research participation and biospecimen
donation; heterotopic ossification (bone growth and episodic flare-ups); other signs and
symptoms by body system; patient-reported outcomes (physical functioning, pain, fatigue, and
general health); and assistive devices, aids, attendants, and adaptations. Because the
Registry is designed to accommodate participants along a broad spectrum of FOP disease
severity, most of the data fields are optional, allowing participants a high degree of
flexibility in how much information they contribute, which also minimizes participant
burden.
After completing the informed consent, participants enter their baseline (historical) data.
Participants will be encouraged to update their information at least twice per year.
Participants may withdraw their consent at any time without prejudice or providing an
explanation. The Registry has no pre-specified end date and will continue for as long as it
is sustainable and useful to the FOP community.
captures demographic and disease data directly from FOP patients and their caregivers via a
secure, web-based patient portal. No experimental intervention is involved. 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.
The Registry collects data through two sources. First, the Patient Portal (launched in July
2015) allows FOP patients and caregivers to enter information about their experiences living
with FOP. Second, the Physician Portal (in development) will allow physicians to enter
clinical data about patients under their care. The Registry will be capable of including
data on specific marketed therapies under the direction and control of a sponsoring
pharmaceutical company. Key identifiers will link the physician-reported data with the
Patient Portal data.
Participants must have a confirmed diagnosis of FOP and the participant (or a parent or
legal guardian) must be willing and able to provide written informed consent. There are no
exclusion criteria. Data collected in the Patient Portal include: patient demographics and
diagnosis pathway; medical and dental care; clinical research participation and biospecimen
donation; heterotopic ossification (bone growth and episodic flare-ups); other signs and
symptoms by body system; patient-reported outcomes (physical functioning, pain, fatigue, and
general health); and assistive devices, aids, attendants, and adaptations. Because the
Registry is designed to accommodate participants along a broad spectrum of FOP disease
severity, most of the data fields are optional, allowing participants a high degree of
flexibility in how much information they contribute, which also minimizes participant
burden.
After completing the informed consent, participants enter their baseline (historical) data.
Participants will be encouraged to update their information at least twice per year.
Participants may withdraw their consent at any time without prejudice or providing an
explanation. The Registry has no pre-specified end date and will continue for as long as it
is sustainable and useful to the FOP community.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- There are no exclusion criteria.
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