Amyotrophic Lateral Sclerosis (ALS) Tissue Donation Program

NCT00716131 | Completed

• 1 other identifier: Internal-16827
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis; Neurodegenerative Disease; Motor Neuron Disease

Keywords

Amyotrophic Lateral Sclerosis; Cerebrospinal Fluid; Neurodegenerative Disease; Motor Neuron Disease; Autonomic Nervous System; Neurodegenerative Diseases; Movement Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Any person with a non-neurologic chronic and poorly controlled systemic illness

Sponsors & Collaborators

• Drexel University College of Medicine: lead
• MDA/ALS Center of Hope: collaborator

Study Sites (1)

MDA/ALS Center of Hope

Philadelphia, Pennsylvania, 19107, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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)

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Neurodegenerative Diseases; Motor Neuron Disease; Movement Disorders

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Terry D Heiman-Patterson, MD

  Drexel University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Nurse Coordinator

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: April 1, 2007
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 6, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)