Amyotrophic Lateral Sclerosis (ALS) Tissue Donation Program

NCT ID: NCT00716131

Last Updated: 2017-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 205 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2016-11-30

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

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

ALS

Diagnosed with ALS or other motor system disorder including PLS, Bulbar Palsy or Motor neuropathy

No interventions assigned to this group

Neuro

Diagnosed with other chronic neurologic illnesses (Alzheimers, multiple sclerosis, migraines, etc)

No interventions assigned to this group

Healthy

Normal Controls

No interventions assigned to this group

Autopsy

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MDA/ALS Center of Hope

OTHER

Sponsor Role: collaborator

Drexel University College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Christine Barr

Research Nurse Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Terry D Heiman-Patterson, MD

Role: PRINCIPAL_INVESTIGATOR

Drexel University College of Medicine

Locations

MDA/ALS Center of Hope

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

Internal-16827

Identifier Type: -

Identifier Source: org_study_id