PRECISION ALS
Research type
Research Study
Full title
Prospective Pan-European Study of ALS Using an Integrated Patient Data Platform (PRECISION-ALS)
IRAS ID
328636
Contact name
Christopher McDermott
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS FT
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
PRECISION-ALS is an academic /industry research collaboration between the European ALS Consortium TRICALS (Treatment Initiative to Cure ALS (www.Tricals.org) and 2 Science Foundation Ireland Research Centres, FutureNeuro and ADAPT.
The leader of the project is Professor Hardiman of Beaumont Hospital and Trinity College Dublin (Co-Chair of TRICALS, along with Professor van den Berg from University Medical Centre, Utrecht).
The purpose of PRECISION-ALS is to develop a bespoke European patient data platform that will collect and analyse precision-medicine oriented clinical data related ALS/MND from patients. This data platform will enable TRICALS researchers and companies to develop a precision medicine approach towards new treatments, such that the right drug is developed and provided for the right patient at the right time.
This observational study sits within the contest of a multi-national, multi-centric, observational population-based study that will collect multimodal data from European ALS patients to explore natural history, identify sub-cohorts, develop and evaluate disease biomarkers, and where relevant, collect data on emerging DMTs, in a real-world setting prospectively. Data from consenting patients will be collected in the context of regular visit schedule. All consenting patients with a confirmed ALS diagnosis are eligible for inclusion on this Patient Data Platform, and cross- and multimodal data analysis will be conducted.
The observational design of this study allows the observation of patients in a broad range of settings reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the full discretion of the treating physician without interference by the platform or data collection protocol.
REC name
South West - Frenchay Research Ethics Committee
REC reference
24/SW/0047
Date of REC Opinion
10 Sep 2024
REC opinion
Further Information Favourable Opinion