Establishment of a Tissue Bank (Blood, CSF) for the Understanding of Motor Neuron Disease (MND) (WBC)
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|ClinicalTrials.gov Identifier: NCT01950910|
Recruitment Status : Suspended (Measures are being taken to recruit a research scientist)
First Posted : September 26, 2013
Last Update Posted : December 27, 2019
|Condition or disease|
|Amyotrophic Lateral Sclerosis|
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 to better understand the progression of this disease.
Samples from patients that have a confirmed or unknown diagnosis of motor neuron disease will be examined. ALS and suspected neuromuscular disease (control) samples will be collected for comparison. Investigators will examine various biochemical, metabolic and genetic markers from these samples in hopes of finding differences in the expression between control subjects and ALS patients and how these biomarkers vary during disease progression. Participants will be asked to complete an optional questionnaire to collect data including medication and vitamin use and medical and disease history. This data will be linked to the patient's samples; however, all samples will be deidentified and coded to avoid the possibility of linking results to the patient. Results will not be stored in the patient's medical record.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Establishment of a Tissue Bank (Blood, CSF) for the Understanding of the Disease Progression and Early Diagnosis of Motor Neuron Disease (MND).|
|Actual Study Start Date :||March 29, 2004|
|Actual Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||December 31, 2030|
subjects w/ non-motor neurodegenerative disease
subjects with ALS or with non-motor neurodegenerative disease
subjects w/out motorneuron degenerative dis
subjects without motorneuron degenerative disease
- Levels of ALS biomarkers in blood [ Time Frame: After blood is collected from study subjects. Data will be analyzed at one year. ]Blood samples will be processed to obtain serum samples and to isolate peripheral blood mononuclear cells (PBMC's). Serum samples will be analyzed for biochemical and metabolic markers of interest and future cell culture as needed. PBMCs will be processed for RNA, DNA or protein isolation. Aliquots of all samples will be stored for future study.
- Levels of ALS biomarkers in CSF [ Time Frame: After CSF is collected from study subject. Data will be analyzed at one year. ]CSF samples will be processed and assayed for biomarkers of interest. An aliquot of CSF sample will be stored for future study.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950910
|United States, North Carolina|
|Neurosciences Institute, Neurology - Charlotte|
|Charlotte, North Carolina, United States, 28207|
|Principal Investigator:||Benjamin R Brooks, MD||Neurosciences Institute, Neurology - Charlotte|