An Observational Study of Epilepsy: Biology and Outcomes Using Real-world Data
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this observational study is to learn more about phenotypic, genetic, biochemical, neurophysiological and radiological patterns in epilepsy. Participants will be asked to consent to use of clinical and paraclinical data (obtained during standard care) for research, and will be asked to donate blood samples at their routine clinic visits.
Detailed description
This is an observational study of people with epilepsy seen in South Wales, which will employ quantitative methods of analysis to meet the study aims. The study will build upon data already collected during routine clinical appointments from people with epilepsy who have come into contact with the National Health Service (NHS) epilepsy service at Cardiff \& Vale University Health Board. The epilepsy service has clinical data on over 5000 people with epilepsy, and biological samples on approximately 400 people through the Welsh Neuroscience Research Tissue Bank.
The investigators propose to approach individuals being seen in the epilepsy clinics to gain consent for access to their routinely collected clinical and paraclinical data, and prospective donation of biological samples (predominantly blood samples, though consent will be sought for surplus brain tissue and cerebrospinal fluid (CSF) if brain surgery or lumbar puncture are being performed as part of clinical care, as well as hair, nail, and urine in some circumstances). This will enable a comprehensive disease register of a population-based sample of people with epilepsy to be established.
Interrogating the clinical and paraclinical data will allow investigation into clinical phenotypes, short- and long-term outcomes in epilepsy, and the relationship of clinical, demographic and biological variables. Biological samples will allow biochemical and genetic analysis of potential markers of disease, clinical phenotype, and prediction of outcomes including treatment responses, and allow contribution to the Epi25 international collaborative (http://epi-25.org/).
Inclusion in the study will involve no change to the normal clinical care or treatment of participants (except where participants choose to provide biological samples), and additional clinic visits will not be required outside of standard NHS care.
Primary outcome measures
- Establish population-based cohort of people with epilepsy [Time frame: 10-years]
Eligibility criteria
Inclusion criteria
- Individual is being investigated for epilepsy and under the clinical care of the epilepsy unit at Cardiff \& Vale University Health Board or regional clinics in Cwm Taf.
- Individual is at least 16 years old.
- Informed consent sought and given by individual.
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Cardiff and Vale UHB — Cardiff
Identifiers
NCT: NCT05632978 · 8345