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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
Sponsor:
Information provided by (Responsible Party):
Benjamin Rix Brooks, Atrium Health

Brief Summary:
Biomarkers are essential for the identification of disease states. There are no early diagnostic or prognostic markers for ALS. The purpose of this study is to identify a panel of biomarkers from blood or spinal fluid of ALS patients and to collect data to better understand disease progression.

Condition or disease
Amyotrophic Lateral Sclerosis

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
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


Group/Cohort
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



Primary Outcome Measures :
  1. 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.

  2. 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
blood samples (serum and protein/RNA/DNA from blood cells) and CSF


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ALS patients in the Charlotte, NC, area.
Criteria

Inclusion Criteria:

  • 18 years old or older

Exclusion Criteria:

  • less than 18 years old

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Neurosciences Institute, Neurology - Charlotte
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Benjamin Rix Brooks
Investigators
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Principal Investigator: Benjamin R Brooks, MD Neurosciences Institute, Neurology - Charlotte

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Responsible Party: Benjamin Rix Brooks, Medical Director, Neuromuscular/ALS-MDA Center and Neuromuscular/ALS Research Laboratory, Atrium Health
ClinicalTrials.gov Identifier: NCT01950910    
Other Study ID Numbers: CHS-Neurology-WBC Tissue Bank
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: December 27, 2019
Last Verified: December 2019
Keywords provided by Benjamin Rix Brooks, Atrium Health:
Amyotrophic lateral sclerosis
motor neuron disease
biological markers
biomarkers
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases