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

NCT ID: NCT01950910

Last Updated: 2022-07-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 766 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-03-29
• Study Completion Date: 2020-10-29

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.

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

subjects w/ non-motor neurodegenerative disease

subjects with ALS or with non-motor neurodegenerative disease

No interventions assigned to this group

subjects w/out motorneuron degenerative dis

subjects without motorneuron degenerative disease

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 18 years old or older

Exclusion Criteria

• less than 18 years old

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin R Brooks, MD

Role: PRINCIPAL_INVESTIGATOR

Neurosciences Institute, Neurology - Charlotte

Locations

Neurosciences Institute, Neurology - Charlotte

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

CHS-Neurology-WBC Tissue Bank

Identifier Type: -

Identifier Source: org_study_id