Amyotrophic Lateral Sclerosis (ALS) Tissue Donation Program

This study is currently recruiting participants.
Verified October 2013 by Drexel University
Sponsor:
Collaborator:
MDA/ALS Center of Hope
Information provided by (Responsible Party):
Christine Barr, Drexel University
ClinicalTrials.gov Identifier:
NCT00716131
First received: July 14, 2008
Last updated: October 15, 2013
Last verified: October 2013

July 14, 2008
October 15, 2013
April 2007
December 2014   (final data collection date for primary outcome measure)
None Specified [ Time Frame: None Specified ] [ Designated as safety issue: No ]
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.
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Complete list of historical versions of study NCT00716131 on ClinicalTrials.gov Archive Site
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Amyotrophic Lateral Sclerosis (ALS) Tissue Donation Program
ALS Tissue Donation Program

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.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Description:

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)

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.

  • Amyotrophic Lateral Sclerosis
  • Neurodegenerative Disease
  • Motor Neuron Disease
Not Provided
  • ALS
    Diagnosed with ALS or other motor system disorder including PLS, Bulbar Palsy or Motor neuropathy
  • Neuro
    Diagnosed with other chronic neurologic illnesses (Alzheimers, multiple sclerosis, migraines, etc)
  • Healthy
    Normal Controls
  • Autopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Christine P Barr, RN 267-507-2633 cbarr@drexelmed.edu
Contact: Lauren Scull, MS 267-507-6329 lscull@drexelmed.edu
United States
 
NCT00716131
Internal-16827
No
Christine Barr, Drexel University
Drexel University College of Medicine
MDA/ALS Center of Hope
Principal Investigator: Terry D Heiman-Patterson, MD Drexel University College of Medicine
Drexel University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP