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Sponsors and Collaborators: |
Drexel University MDA/ALS Center of Hope |
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Information provided by: | Drexel University |
ClinicalTrials.gov Identifier: | NCT00716131 |
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.
Condition |
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Amyotrophic Lateral Sclerosis Cerebrospinal Fluid Neurodegenerative Disease Motor Neuron Disease |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | ALS Tissue Donation Program |
Blood (Serum and DNA) Urine (Serum and DNA) CSF Blood specimens and tissue specimens (from brain, spinal cord, gastrointestinal tract, skeletal muscle and peripheral nerve)
Estimated Enrollment: | 300 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | December 2014 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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ALS
Diagnosed with ALS or other motor system disorder including PLS, Bulbar Palsy or Motor neuropathy
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Neuro
Diagnosed with other chronic neurologic illnesses (Alzheimers, multiple sclerosis, migraines, etc)
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Healthy
Normal Controls
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Autopsy |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
ALS clinic patients at MDA/ALS Center of Hope, along with families and caregivers. Also those with ALS who have donated their bodies to research.
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
MDA/ALS Center of Hope | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Christine Barr, RN 215-762-5186 cbarr@drexelmed.edu | |
Principal Investigator: Terry Heiman-Patterson, MD |
Responsible Party: | MDA/ALS Center of Hope ( Terry Heiman-Patterson, MD ) |
Study ID Numbers: | Internal-16827 |
Study First Received: | July 14, 2008 |
Last Updated: | July 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00716131 |
Health Authority: | United States: Institutional Review Board |
Amyotrophic Lateral Sclerosis Cerebrospinal Fluid Neurodegenerative Disease Motor Neuron Disease |
Autonomic Nervous System Neurodegenerative Diseases Movement Disorders |
Amyotrophic lateral sclerosis Neuromuscular Diseases Spinal Cord Diseases Movement Disorders Amyotrophic Lateral Sclerosis Central Nervous System Diseases |
Lou Gehrig's disease Sclerosis Degenerative motor system disease Neurodegenerative Diseases Motor neuron disease Motor Neuron Disease |
Pathologic Processes Nervous System Diseases |