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The Insight Registry is an online registry for people with Ocular Melanoma. It is sponsored by A Cure in Sight and hosted by the National Organization for Rare Disorders (NORD®) on their IAMRARE® platform. This registry will collect information from participants (or their authorized representatives) who are affected by Ocular Melanoma. Ocular Melanomas (OM) are eye cancers that affect about 5 individuals per million in the population per year. Most cases present in adulthood, peaking around the age of 60 years. Caucasians with light colored eyes are at particular risk, comprising around 94% of cases. Both sexes are affected in equal numbers. Approximately 98% arise within the uvea of the eye (more than 90% choroid, the remainder in the iris and ciliary body). Conjunctival melanomas (CM) account for 2% of OMS, developing in the transparent “skin” lining the front of the eye and the inner surface of the eyelids. Diagnosis is made clinically (in the office) by an ophthalmologist, based on the appearance of the tumor on examination, ultrasonography, and other diagnostic scans.
Treatment of uveal Melanoma (UM) is usually by plaque radiotherapy (brachytherapy) or proton beam radiotherapy, which are aimed at preventing metastatic disease while conserving the eye and useful vision. If these are considered unlikely to conserve a useful eye, the patient is treated by enucleation (ocular amputation).
Metastatic disease from UM develops in almost 50% of patients, usually in the liver. CMs behave more like skin melanomas, spreading through lymphatics to cervical nodes before developing in the lungs and other organs. Almost all patients with metastatic disease die within two years of the onset of symptoms, despite treatment. Metastatic ocular melanoma is treated with systemic chemotherapy and immunotherapy drugs.
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What is a Patient Registry?
A patient registry is a collection of standardized information about a group of patients who share a condition. The information may be used for a variety of purposes such as conducting natural history studies and supporting disease-specific clinical trial recruitment. The Insight Registry serves to:
- Support the design of clinical trials that explore new rare disease treatments.
- Describe the people who have Ocular Melanoma and to better understand the variability and stages of Ocular Melanoma;
- Understand how Ocular Melanoma changes over a person’s lifetime;
- Learn about clinical practice patterns and variations over the course of treatment;
- Help to develop best practices, management guidelines, and recommendations so that clinicians can know how to give the best care to improve the quality of life and outcomes of people with Ocular Melanoma; and
- Identify people with Ocular Melanoma who might be willing to take part in other research studies or clinical trials. You will be able to choose whether you want to hear about these other studies.
Objectives
The primary aim of the INISIGHT Global Ocular Melanoma (OM) Registry (INSIGHT Registry) is to conduct a prospective, efficient natural history study that will result in the most comprehensive understanding of the disease and its course over time. Other registry objectives include the following:
- Provide a convenient online platform for participants (or caregivers) to self-report cases of OM
- Develop a communications registry within the INSIGHT Registry (e.g., to notify patients of research studies and clinical trials)
- Characterize and describe the OM population as a whole, enhancing the understanding of disease prevalence and phenotype as well as the rate of progression of disease characteristics.
- Assist the OM community with the development of recommendations and standards of care.Be a case-finding resource to be used for researchers who seek to study the pathophysiology of OM retrospectively collate intervention outcomes, and design prospective trials of novel treatments
What types of data will be collected in the Insight Registry?
The Insight Registry collects data on the following topics:
- Socio-demographics
- Medical history and diagnostics
- Treatment and disease progression
- Management of care
- Quality of life
- Mental Health
- Metastatic disease progression
- Access to care related to the COVID-19 pandemic
Is the data secure?
The Insight Registry follows strict government guidelines to assure patient information is protected. The platform is served over HTTPS, which means that the data is encrypted when being sent from the user’s browser to the NORD servers. The data is also kept encrypted in the NORD database (data at rest). Communications between the registry platform application server and the database are also encrypted. As with any information one provides electronically, there is a very rare chance that privacy could be compromised. However, the registry and the security measures minimize the chance of this occurring.