Clinical Trial: Establishment of a Tissue Bank (Blood, CSF) for the Understanding of the Disease Progression and Early Diagnosis of Motor Neuron Disease (MND)
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational
Official Title: Establishment of a Tissue Bank (Blood, CSF) for the Understanding of the Disease Progression and Early Diagnosis of Motor Neuron Disease (MND).
Brief Summary: Amyotrophic lateral sclerosis (ALS) is a motor neuron disease characterized by progressive degeneration of motor neurons, muscle atrophy and paralysis. There is no reliable early diagnostic test for ALS, making identification of the disease difficult at its earliest stages. Early detection is critical to the initiation of early neuroprotective therapy. By the time a reliable diagnosis can be made, substantial damage to motor neurons and muscle has already occurred. The purpose of the current project is to establish a bank of blood samples (serum and protein/RNA/DNA from blood cells) and CSF for use in the development of an early diagnostic test for ALS and for better understanding the progression of this disease. The main idea of the current study is to examine samples from patients that have a suspected diagnosis of motor neuron disease, including patients with ALS who have not progressed far enough to be definitively diagnosed as having ALS. Normal and disease control samples will be collected for comparison. The investigators will examine various biochemical and metabolic markers from these samples, in hopes of finding differences in their expression between control subjects and ALS patients and during disease progression. Ultimately, the investigators would like to have a panel of markers from the blood that would allow us to diagnose and follow the progression of ALS from the earliest possible moment. The data collected from this project would give us a basis for a fairly non-invasive, quick and clinically relevant test for the early diagnosis of ALS. This in turn would allow us to provide earlier intervention for these patients, possibly slowing the damage and improving prognosis.
Detailed Summary:
Sponsor: Benjamin Brooks
Current Primary Outcome:
- Levels of ALS biomarkers in CSF [ Time Frame: After CFS is collected from study subjects. Data will be analyzed at one year. ]
- Leves of ALS biomarkers in blood [ Time Frame: After blood is collected from study subject. Data will be analyzed at one year. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Carolinas Healthcare System
Dates:
Date Received: March 30, 2013
Date Started: June 2007
Date Completion: January 2015
Last Updated: July 2, 2014
Last Verified: July 2014
