Clinical trial NCT01950910: Establishment of a Tissue Bank (Blood, CSF) for the Understanding of Motor Neuron Disease (MND)
Official title: Establishment of a Tissue Bank (Blood, CSF) for the Understanding of the Disease Progression and Early Diagnosis of Motor Neuron Disease (MND).
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis
motor neuron disease
biological markers
biomarkers
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-09-26
Enrollment: 766
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALS patients in the Charlotte, NC, area.

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.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older

Exclusion Criteria:

* less than 18 years old

Primary outcomes:
measure: Levels of ALS biomarkers in blood
timeFrame: After blood is collected from study subjects. Data will be analyzed at one year.
measure: Levels of ALS biomarkers in CSF
timeFrame: After CSF is collected from study subject. Data will be analyzed at one year.
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Neurosciences Institute, Neurology - Charlotte
state: North Carolina
Study officials:
affiliation: Neurosciences Institute, Neurology - Charlotte
name: Benjamin R Brooks, MD
role: PRINCIPAL_INVESTIGATOR
References: