Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
ALS Tissue Donation Program
Verified date | January 2017 |
Source | Drexel University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
Despite significant progress in the identification of mechanisms involved in motor neuron
degeneration in Amyotrophic Lateral Sclerosis (ALS) and other motor system diseases, the
actual pathogenesis and cause of these diseases remains unknown. Effective treatment of
these diseases are dependent on the elucidation of their causes. The availability of
diseased and control human tissues will be a critical resource for this research progress. .
Samples of serum, spinal fluid, and urine from patients with motor system diseases can be
used to study biochemical and genetic differences compared to tissues of neurologic disease
controls and normal controls. Furthermore, the availability of autopsied CNS, PNS, as well
as other tissues from patients with ALS or suspected ALS are useful for current and future
research studies into the disease. Therefore, we propose to institute a Tissue Bank
containing blood, urine, and cerebrospinal fluid donated from not only ALS and other motor
neuron disease patients, but also those with other neurologic diseases and normals whose
tissue can be used as controls. In addition there will be an autopsy band for post-mortem
specimens of ALS and other motor neuron disease patients. Each specimen, whether from a
living patient or autopsy will be de-identified and accompanied by a standard set of
clinical information collected from the medical records in order that each specimen is
characterized with the relevant clinical information to maximize the usefulness of the
specimens.
Once established, this tissue bank will provide a resource in which a large number of
samples will be readily available and expedite research by circumventing the delays in
collecting specimens prospectively. These specimens will be used for research in the ALS
Center of Hope at Drexel University College of Medicine and shared with any outside
investigator with a valid IRB approved protocol.
Status | Completed |
Enrollment | 205 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosed with ALS or other motor system disorder including PLS, Bulbar Palsy or Motor neuropathy - Diagnosed with other chronic neurologic illnesses (Alzheimers, multiple sclerosis, migraines, etc) - Normal Controls - In the case of spinal fluid collection, the patient will be undergoing a diagnostic lumbar puncture as part of the work-up Exclusion Criteria: - Any person with a non-neurologic chronic and poorly controlled systemic illness |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | MDA/ALS Center of Hope | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Drexel University College of Medicine | MDA/ALS Center of Hope |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | None Specified | No primary outcome measure is specified for this study. Purpose of the study is to collect deidentified biological specimens which will be used to expedite other IRB approved studies. | None Specified | No |
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