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The FOP Registry launched in 2015 as the first global patient registry open to all individuals with a diagnosis of fibrodysplasia ossificans progressiva (FOP). A patient registry is a place where medical information, family history, and other related information from people living with a condition is collected and stored for medical research. The FOP Registry is sponsored by the International FOP Association (IFOPA).
The goal of the Registry is to support and inform the FOP community while advancing research. It helps keep individuals and families aware of clinical trials and related research opportunities, while also giving researchers a clearer understanding of how FOP affects people’s lives.
By collecting information over time, the Registry provides insight into each patient’s experience, including their diagnosis journey, treatments, and overall health. It gathers data on demographics, medical and dental care, and key aspects of living with FOP such as fractures, blood clots, flare-ups, mobility, extra bone growth, reproductive health, mental health, and pain.
This information helps drive continued research and improves understanding of the scope and impact of FOP across the community.
When you join the Registry, you are asked to share information about yourself, your FOP, and your overall health. This includes details about your diagnosis, changes in symptoms, and your experiences over time. Participants are encouraged to update their information every six months so researchers can better understand how FOP progresses and impacts individuals.
The information you provide plays an important role in advancing research and improving care. It helps scientists and clinicians better understand FOP, which in turn supports better clinical decision-making and improves the care patients receive. It also helps researchers develop more effective treatments and design clinical trials that are critical to finding new therapies.
The Registry also benefits you directly. It can connect you with helpful resources to support the management of your condition, allow you to track your symptoms and
FOP progression, and share information about clinical trials or research studies that you may be eligible for and interested in.
The data you share in the Registry is made available to researchers and doctors working on FOP. However, your identity is always protected. The information you provide may help speed up research by providing scientists with important new information and insights on FOP. Medical professionals may be able to improve how they take care of people living with the condition.
Anyone with a diagnosis of fibrodysplasia ossificans progressiva (FOP) can join. However, if you are not an adult (18 years old or older), you must have permission from a parent or legal guardian to join. In this case, your parent or legal guardian should sign up for the Registry with their information, then create a profile for you in their account.
When you decide to join the FOP Registry, you will be guided through a simple sign-up process and provide your consent to participate (this is known as informed consent). You will then be permitted access to the FOP Registry platform and asked to enter your medical information and complete the online Registry questionnaires, a process similar to completing any other online questionnaire.
When you sign the Informed Consent Form (ICF), you agree to join the FOP Registry. The informed consent form provides all the details about what you agree to, which includes:
The data you provide will be used to do research and shared with researchers and medical professionals. However, your identity is always protected.
The data you provide can be used to connect you with clinical trials and other research studies that you may be a good fit for, and perhaps, interested in participating in.
You will have the option to link your FOP Registry information with FOP Biobank samples (if applicable). The FOP Biobank stores biological samples (i.e. blood, urine, saliva and baby teeth) kindly provided by individuals with FOP that are made available to FOP researchers to study.
If you previously participated in the Clementia Pharmaceutical’s FOP Natural History Study, you could also choose to give permission for the IFOPA to receive your data from the FOP Natural History Study database. This data will be added to the FOP Registry database (if applicable).
After enrolling in the FOP Registry patient portal, you will be asked to complete online questionnaires. These questionnaires collect information about your condition, including your diagnosis, changes in symptoms, medical history, quality of life, and your experiences over time.
You will be asked to update your information in the Registry every six months. The Registry will send email reminders when it’s time to complete your updates and questionnaires.
If the Registry is unable to reach you over time, your account may become inactive.
If you no longer want to take part, you can withdraw your consent from your profile management page or contact the FOP Registry team. You may choose to leave your de-identified information in the Registry or have your data removed from the database. Data shared prior to your request for removal cannot be retrieved from researchers that have already accessed it.
No, there are no costs to join or take part in the FOP Registry.
If you enroll in the FOP Registry patient portal, you will be asked to provide personal and health information, including:
Contact and identifying information:
First and last name
Date of birth
Email address
Phone number
Home address
Demographic information:
Sex assigned at birth
Race or ethnicity
Health and medical information:
Medical history, including past conditions
Mental health information
Dental care
FOP-specific information:
Diagnosis and disease progression
Flare-ups
Fractures and blood clots
Mobility and movement
Extra bone growth
Reproductive health
Pain and symptom changes over time
This information is collected over time to help researchers and clinicians better understand FOP and improve patient care.
The FOP Registry team is committed to protecting your personal information, such as your name and contact details.
The personal information you provide in the Registry will be used only for FOP Registry-related communications.
If you are a member of IFOPA, the contact information you provided at sign-up may also be used to share other relevant IFOPA updates and communications with you.
You may choose to opt out of communications at any time.
Your personal information will never be shared with others without your permission.
We take your privacy seriously and use your information only to support and communicate with you.
Researchers, doctors, Registry sponsors, and pharmaceutical companies may submit written requests for data from the FOP Registry. Upon receipt, IFOPA Registry staff review each request and, when appropriate, share it with the FOP Registry Medical Advisory Board (MAB) for evaluation. The Registry MAB assesses the scientific merit of the request and confirms that the requested data align with the stated research objectives.
Once a request is approved, the Registry may provide the requester with relevant data either in aggregate summary format or as de-identified individual patient-level data, depending on the needs of the approved research. In all cases, the data provided are fully de-identified to ensure that individual participants cannot be identified. Because FOP is an ultra-rare condition, the IFOPA implements enhanced privacy safeguards, including suppression of geographic information for any location in which five or fewer participants reside.
Your de-identified information may be shared with global databases and academic and commercial FOP researchers to develop and further the global knowledge of FOP, which may lead to new research studies, clinical trials for new treatments for FOP, and improvements in the clinical management of FOP.
The IFOPA (the data controller) is the guardian of the information contained within the FOP Registry. Oversight for the Registry will be provided by the IFOPA. With the guidance of the FOP Registry Medical Advisory Board, the IFOPA will determine how the data are used. A protocol for the Registry has been reviewed by the Northstar Institutional Review Board (IRB) to ensure protection of the rights and welfare of participants.
Given the rarity of FOP, re-identification may be possible even without direct identifiers However, ensuring patient privacy is a primary responsibility and concern of the IFOPA. Steps have been taken to make sure the FOP Registry participants’ information is stored in a secure setting. Submitted data is protected by user ID and password. All users accessing the FOP Registry platform are authenticated using a two-factor login system for additional security. The Registry is hosted by Lumiio Inc., who provide the platform that collects and manages the Registry data in a secure, cloud-based system hosted in Amazon Web Services. All Registry data is stored as encrypted data. Your data is coded so that only people authorized to see it can do so. The Registry is fully compliant with U.S. and European regulations for clinical systems including HIPAA, 21 CFR Part 11 and GDPR.
The IFOPA does not rent, sell or share any identifying information from our mailing lists or the FOP Registry to another outside, third-party party (e.g. a vendor contracted to provide services to the IFOPA). The only time your identifying information could be shared with a third-party is if they are involved in linking your FOP Registry data to another data source (e.g., FOP Biobank or the FOP Natural History Study). This will still require your consent and approval. Requests for data from the FOP Registry by researchers, pharmaceutical companies, or doctors are granted only under strict agreements that prohibit any attempt to re-identify participants.
Yes, data is stored on remote servers that are hosted by a cloud service provider in the United States of America. All databases used are encrypted, which is a fundamental security technique that converts data into a coded form, protecting it from unauthorized access or interception.
Yes, data is encrypted during transit and at rest.
To prevent data loss and ensure data accuracy, backups are taken on a regular basis. The backup procedure applies to both server fields as well as to the actual data stored within the database (health and patient-identifying data). All backups are stored on remote servers that are hosted by a third-party provider. The backup schedule is dependent on the type of data stored.
There is not currently an FOP Registry app. However, the web-based interface is optimized to work correctly in a browser on your mobile device.
Yes, your answers will be saved as you complete each survey screen. You can exit the survey and return at any time to complete the remaining questions. Follow-up surveys must be completed within a 30 day window from when they become available to complete. You can start your survey and take a break and the platform will save your answers, but you will need to complete the entirety of the survey before the 30 day window closes.
Children who turn 18 years old while participating in the FOP Registry will be asked to provide consent (reconsent) at that time, if they are capable of doing so.
If the child reconsents, their data will remain and they’ll gain full control over their account.
If they choose to withdraw, their data will no longer be collected or used going forward. However, any de-identified information that has already been shared with researchers before their request cannot be retrieved or withdrawn. If no action is taken, their existing data will remain securely stored, however no one (including their parent/guardian) will be able to add or change anything on their profile except for an Administrator.