About the INSIGHT Registry
The INSIGHT Registry is an online registry for patients with Ocular Melanoma (OM). It will be hosted by the National Organization for Rare Disorders (NORD); an independent non-profit patient advocacy organization dedicated to individuals with rare diseases and the organizations who serve them and as such is committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research, and patient services. The registry will collect information from participants, (or their authorized respondents, heretofore referred to collectively as “participants”), 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.
The INSIGHT Registry is a prospective longitudinal web-based observational natural history study. Participants with Ocular Melanoma will be followed throughout the course of their lives with either the participant or authorized respondents contributing data at varying intervals throughout the course of the study. Data will be collected at the start of the study (baseline), and at various time points or to be updated by the participant as needed. Participants will be asked to enter data into the INSIGHT Registry at least once per year. Data will be collected on demographics, quality of life, medical history, disease phenotypes, event episodic data, retrospective data, participant review of systems and medication and diagnostic data. The driving components to the study include provisions for a convenient online platform for participants; developing a communications registry within the INSIGHT Ocular Melanoma registry; characterizing and describing the Ocular Melanoma population as a whole; assisting the Ocular Melanoma community with the development of recommendations and standards of care and; being a case-finding resource to be used for researchers who seek to study the pathophysiology of Ocular Melanoma.
This registry will be open for five years with the option to renew registration. There is no date of termination or closure.
The data obtained from you for this Registry will be sent to the data bank along with the following information about you, which will be entered into a computer (the database) that is used for research purposes:
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:
Frequently Asked Questions
What is a Patient Registry?
A patient registry is a collection of standardized information about a group of patients who share a condition and is used for a variety of purposes such as conducting natural history stud-ies and supporting disease specific clinical trial recruitment.
The INSIGHT Global Patient Registry is a data gathering informational repository funded and sponsored in part by A Cure in SightTM (ACIS) and the University of California, San Francisco Beckman Vision Center (UCSF). ACIS and UCSF have spent considerable time working to research the best possible way to capture valuable information that will assist in understanding and treating the rare disease that is ocular melanoma. Initially, the registry will be made available to a small group, with the full intent of making this a global effort.
The INSIGHT Patient Registry will provide the means online to collect, store, and retrieve data for the purpose of providing data for analytics in research studies. The registry will fulfill the following roles:
What types of data will be collected in the INSIGHT Registry? Is the data secure?
The INSIGHT Patient Registry collects data on the following topics:
The INSIGHT Global Patient Registry follows strict government guidelines to assure patient information is protected. The registry platform is served over HTTPS, providing encryption of traffic to prevent eavesdropping and man-in-the-middle attacks. Communication between the registry platform application server and the database are also encrypted. Great means are taken to ensure security of data for patients and quality of data for clinical researches.
What is a Natural History Study?
A natural history study is a study designed to track the course of a disease over time and in-cludes people who have a specific medical condition or disease and those who are at risk of de-veloping such. This method of research explores the disease in a comprehensive way and iden-tifies demographic, genetic, environmental, and other variables that correlate with the disease and its outcomes. Natural history studies have many potential uses such as patient care best practice developments and clinical trial recruitment.
Who is a study participant?
A study participant is the individual who takes part in a research study and whose information is collected for that research. Study participants may consent to enter and share their own per-sonal data.
Who is a reporter/respondent?
A reporter/respondent is an individual who completes the surveys on behalf of the patient/study participant, when they are unable to do so on their own behalf.
Who can join the study?
This study is open to anyone who has a Choroidal, Ciliary body, Iris or Conjunctival Melanoma.
Is there a cost to participate?
There is no cost to the patient to join this study. A Cure In Sight and the University of California San Francisco Beckman Eye Center absorbs the cost of the registry for its members.