CURE OM Patient Registry
The CURE OM Patient Registry is a patient-powered research project funded and sponsored by the Melanoma Research Foundation’s CURE OM initiative. The Registry was first conceptualized in at the CURE OM Patient and Caregiver Symposium in 2016 and in the ensuing time, rare disease experts, community stakeholders, key opinion leaders and staff have spent considerable time researching the registry landscape, developing the data set and establishing best practices. The goal is to launch the registry in early 2020 and start recruitment in the United States with the intent of opening the study to participants worldwide thereafter. Collaborators across all sectors have been and continue to be engaged and support the registry. Together all parties will make a difference.
To date, it has been difficult for the medical community to have access to information that would better inform ocular melanoma (OM) prevention, diagnostics, treatments and outcomes. Experts agree the best way to address this challenge is to conduct a natural history study utilizing a patient-reported registry that can streamline and harmonize data collection from patients worldwide. Advocacy organizations and researchers will be able to access and analyze data from a single source that will enhance knowledge and understanding. In time, the registry study could show disease patterns, anomalies and uncover new findings that eventually lead to a cure. The CURE OM initiative’s patient community and collaborators have supported the initiative from the start and continue to work diligently to see the registry through to its launch and success.
What is a Patient Registry?
A patient registry is a collection of information about a group of patients who share a condition or experience. The information is submitted by patients in a confidential, online database that collects data and securely stores it to produce research reports on the condition. These reports can then be shared with registry participants and researchers.
There may be several purposes for a patient registry, including, but not limited to, the following:
- to learn about a disease or condition
- to support prevention
- to support timely diagnosis
- to develop therapies
- to develop research hypotheses
- to improve the quality of health care
- to inform & educate the OM Community
- to inform patient preferences and study quality of life
- to bring together the patient community & research collaborators
- to ensure that patients play an active role in research and treatment advances.
Patient registries are transforming the research landscape in rare diseases like ocular melanoma. They are a critical tool for leveraging patient input, engaging patients in research priorities and improving outcomes.
What Will the CURE OM Registry Accomplish?
Under a structured Institutional Review Board (IRB)-approved protocol and on a data-secure platform, the Melanoma Research Foundation’s CURE OM Patient Reported Registry will capture comprehensive information on genetics, disease characteristics, environment, types of treatments, physical outcomes and quality of life. It will also inform research initiatives focused on policy, patient preferences and standards of care. Consent from participants to contribute their information and their data will be closely monitored for safety and quality under clear systematic procedures. Once patients have entered their data online, the data will be analyzed by the MRF and its collaborating researchers. Outcomes will then be shared with the OM community and other interested, eligible parties to advance knowledge and implement evidence-based change for patients. The data collected over time that captures the progression and lifetime of the disease tells a story; and the greater the participation the more comprehensive the story.
What Has Been Done So Far?
The MRF’s CURE OM initiative has achieved several milestones toward developing a patient-powered, patient-reported registry. After working closely with the ocular melanoma community to raise the initial funds to initiate the project, CURE OM hired a patient-centered research expert, Ms. Jacqueline Kraska. In her role, Ms. Kraska oversees the development of the CURE OM Patient Registry and brings more than fifteen years of experience in clinical research and patient reported registries.
The CURE OM initiative organized an interdisciplinary Patient Registry Steering Committee comprised of patients, caregivers and ocular melanoma clinicians and researchers who meet both in person and via conference calls to support the development of the CURE OM Patient Registry. Specifically, this past year, the committee expanded to include a few additional areas of expertise including: epidemiology, biostatistics and a researcher from the National Eye Institute. Along with guidance from this committee, CURE OM incorporated input from ocular melanoma patients, survivors, caregivers, physicians and researchers through an international online survey which helped define the project’s objectives and main features for the registry. CURE OM then thoroughly assessed different registry models and service providers to determine the best platform to host the CURE OM Patient Registry and ensure its objectives are met. The aims, objectives and desired outcomes have been finalized and the study documents (including the protocol, consent form and data set) are now being developed, along with a registry web page on the MRF website and other communication assets to drive participant engagement and retention.
Additionally, the CURE OM team and its partners have presented on the registry at conferences in the US and abroad, starting with the 7th Annual Eyes on a Cure: Patient & Caregiver Symposium in 2018; view a video recording of the complete presentation here. Also, in October 2018 members of the Steering Committee (including Drs. Bertil Damato, Marlana Orloff and Richard Carvajal) presented at the Society for Melanoma Research Congress in Manchester, England. Then in March 2019, Steering Committee member Dr. Dan Gombos from MD Anderson Cancer Center gave a presentation at the International Society of Ocular Oncology in Los Angeles CA. On April 15, the CURE OM Patient Registry Steering Committee also held an in-person meeting at the 8th Annual Eyes on a Cure: Ocular Melanoma Patient and Caregiver Symposium in Durham, NC. The following day at the symposium Dr. Rich Carvajal presented a Registry update and a panel of committee members addressed questions from the audience, which can be viewed here.
Throughout the project, the CURE OM registry team remains strongly committed to a plan that will inform, educate and engage the patient community. This includes providing updates at the annual CURE OM Patient and Caregiver Symposium and the production of an online webinar series to provide project updates and offer the opportunity to share feedback and questions with the CURE OM team.
Next steps include finalizing multi-year funding for registry hosting and administration, contracting with the chosen registry service provider and building the technical components of the registry. This will entail further engagement with collaborators in both the US and abroad, as well as finalizing the protocol and gaining regulatory approval for the registry content to ensure utmost patient safety, confidentiality and data security. The CURE OM registry team will regularly update our community of patients, caregivers and collaborators with progress and future plans for the CURE OM initiative’s Patient Reported Registry.
Stay tuned for updates and thank you for your continued support of this important resource! If you have any questions or comments, please email firstname.lastname@example.org.