Disease biomarkers in amyotrophic lateral sclerosis/motor neuron disease
| ISRCTN | ISRCTN28270972 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28270972 |
| Protocol serial number | 6160 |
| Sponsor | Barts and The London NHS Trust (UK) |
| Funder | Motor Neurone Disease Association (UK) (ref: Mal.../Apr08/RF/6039) |
- Submission date
- 11/08/2010
- Registration date
- 11/08/2010
- Last edited
- 12/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ching-Hua Lu
Scientific
Scientific
Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom
| chinghua.lu@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre non-randomised interventional diagnosis trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Disease biomarkers in amyotrophic lateral sclerosis/motor neuron disease |
| Study acronym | ALS Biomarkers Study |
| Study objectives | This study will evaluate the expression of neurofilaments and of other relevant molecules in blood samples taken from individuals with amyotrophic lateral sclerosis at different time points during the development of the disease. Our aim is to validate easily accessible disease biomarkers functioning as reliable predictors of disease severity and capable of providing information about the stratification of the disease phenotypes. Control groups will include healthy individuals and patients with a compressive radiculopathy. Recruitment will take place in four motor neuron disease clinics serving a population of approximately 7,000,000 in North-East London, Herefordshire and Essex. A similar study is currently ongoing in animal models of the disease. |
| Ethics approval(s) | MREC, ref: 09/H0703/27 |
| Health condition(s) or problem(s) studied | Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Motor neurone disease; Disease: Motor neurone disease |
| Intervention | 1. Blood tests 2. Venepuncture Study entry: registration only |
| Intervention type | Other |
| Primary outcome measure(s) |
The rate of neurological decline as measured by the ALS Functional Rating Scale Revised (ALSFR) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Diagnosis of definite or probable amyotrophic lateral sclerosis (ALS) according to the El Escorial Criteria 2. Greater than 16 years of age, either sex |
| Key exclusion criteria | ALS/motor neuron disease (MND) patients unable to consent |
| Date of first enrolment | 24/06/2009 |
| Date of final enrolment | 01/02/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Institute of Neurology
London
WC1N 3BG
United Kingdom
WC1N 3BG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/06/2015 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/09/2016: Publication reference added.
