Establishment of a Tissue Bank (Blood, CSF) for the Understanding of Motor Neuron Disease (MND)

NCT01950910 | Terminated DMC

• 1 other identifier: CHS-Neurology-WBC Tissue Bank
• Study Type: observational
• Target: 766
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic lateral sclerosis; motor neuron disease; biological markers; biomarkers

Outcome Measures

Primary Outcomes (2)

• Levels of ALS biomarkers in blood

  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.

  After blood is collected from study subjects. Data will be analyzed at one year.

• Levels of ALS biomarkers in CSF

  CSF samples will be processed and assayed for biomarkers of interest. An aliquot of CSF sample will be stored for future study.

  After CSF is collected from study subject. Data will be analyzed at one year.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ALS patients in the Charlotte, NC, area.

You may qualify if:

• years old or older

You may not qualify if:

• less than 18 years old

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Neurosciences Institute, Neurology - Charlotte

Charlotte, North Carolina, 28207, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Benjamin R Brooks, MD

  Neurosciences Institute, Neurology - Charlotte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2013
• First Posted: September 26, 2013
• Study Start: March 29, 2004
• Primary Completion: December 31, 2017
• Study Completion: October 29, 2020
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

US (1)