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

Wake Forest University (WFU)

Status: Terminated

Conditions: Amyotrophic Lateral Sclerosis

Study type: Observational

Funder types: Other

Identifiers

NCT01950910

CHS-Neurology-WBC Tissue Bank

Details and patient eligibility

About

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.

Full 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.

Enrollment: 766 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years old or older

Exclusion criteria

• less than 18 years old

Trial design

766 participants in 2 patient groups

subjects w/ non-motor neurodegenerative disease

Description:

subjects with ALS or with non-motor neurodegenerative disease

subjects w/out motorneuron degenerative dis

Description:

subjects without motorneuron degenerative disease