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| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 14, 2008 |
| Last Updated Date | April 6, 2009 |
| Start Date ICMJE | April 2007 |
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00716131 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Amyotrophic Lateral Sclerosis (ALS) Tissue Donation Program |
| Official Title ICMJE | ALS Tissue Donation Program |
| Brief Summary | 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. |
| Detailed Description | |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Case Control, Cross-Sectional |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups |
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| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Estimated Enrollment ICMJE | 300 |
| Estimated Completion Date | December 2014 |
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00716131 |
| Responsible Party | Terry Heiman-Patterson, MD, MDA/ALS Center of Hope |
| Study ID Numbers ICMJE | Internal-16827 |
| Study Sponsor ICMJE | Drexel University College of Medicine |
| Collaborators ICMJE | MDA/ALS Center of Hope |
| Investigators ICMJE | |
| Information Provided By | Drexel University |
| Verification Date | April 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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