Epilepsy-Bio v1.0
Research type
Research Study
Full title
An observational study of epilepsy: biology and outcomes using real-world data
IRAS ID
315983
Contact name
Khalid Hamandi
Contact email
Sponsor organisation
CARDIFF & VALE UNIVERSITY LHB
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 11 months, 31 days
Research summary
Epilepsy is a common but serious neurological condition that can present at any age and is characterised by recurrent and unpredictable brain seizures. The clinical manifestation of epilepsy is highly varied, but accurate diagnosis of the syndrome is important to understand the severity and prognosis of the condition as well as to guide treatment choices.
There is a need for better characterisation and clinical markers of epilepsy, as well as an understanding of how these link with genetic markers of disease. In addition, identifying possible genetic and physiological factors underlying treatment responses to anti-epileptic drugs may help to tailor treatments for people with epilepsy.
‘Real-world (observational) data’ is an important source of information in patient populations. Data collected through routine clinical care of people with epilepsy offers a unique resource and opportunity for clinical research. This study will utilise clinical and paraclinical data collected during routine NHS appointments from people being seen in epilepsy clinics within Cardiff and surrounding regions (over 5000 people). In addition, we will seek consent for prospective collection of biological samples. 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.
Interrogating this 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.
REC name
Wales REC 3
REC reference
23/WA/0066
Date of REC Opinion
12 Apr 2023
REC opinion
Further Information Favourable Opinion