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Trial record 1 of 1 for:    als | National Registry of Veterans
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National Registry of Veterans With Amyotrophic Lateral Sclerosis and DNA Bank (ALS Registry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00076154
Recruitment Status : Completed
First Posted : January 16, 2004
Last Update Posted : April 21, 2014
ALS Association
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Brief Summary:
This study will identify living veterans with amyotrophic lateral sclerosis (ALS) through a national registry that is being developed. Diagnosis of ALS will be verified by study neurologists via medical record review. Registry participation includes a bi-annual telephone interview to collect functional status data.

Condition or disease

Detailed Description:

Primary Objective: To identify as completely as possible all veterans with ALS and to collect data which will be available for approved studies examining the cause(s) of ALS.

Secondary Objective: To provide a mechanism for the VA to inform veterans with ALS about clinical trials and other studies for which they may be eligible.

Primary Outcomes: Identification of all living veterans with ALS.

Intervention: N/A

Study Abstract: Amyotrophic lateral sclerosis (ALS) is an adult-onset, rapidly fatal neuromuscular disease of unknown etiology. ALS is a disease of high priority to the VA, particularly due to ongoing concerns about the health of veterans who served in the Gulf War. Efforts are needed to systematically identify and track veterans with ALS. Accordingly, the Department of Veterans Affairs (VA) is developing a national registry of veterans diagnosed with ALS.

Research Design: The registry will not be designed to test specific hypotheses but will focus on comprehensive identification of veterans with ALS who may be eligible for other studies.

Methodology: Eligible participants will include all living veterans with a physician diagnosis of ALS. Veterans with possible ALS will be identified through VA medical records, the Veterans Benefits Administration (VBA), and self-referral. Neurologists with expertise in ALS will review veterans' medical records to verify the diagnosis and determine eligibility. Upon enrollment, veterans will be asked to complete a brief telephone interview. Registry participants will also be contacted by telephone biannually to assess health and functional status. The VA may notify registry participants about clinical trials for which they may be eligible. A Scientific Review Committee will evaluate all studies that request use of registry data and/or access to Registry participants.

Results: N/A

Impacts: The registry will provide the VA with a valuable mechanism for involving veterans in clinical trials and other studies that may yield improved outcomes for ALS. In addition, data gathered as a part of the registry has the potential to benefit not only veterans, but also the larger community of individuals with ALS.

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Study Type : Observational
Actual Enrollment : 2121 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: CSP #500A - National Registry of Veterans With Amyotrophic Lateral Sclerosis
Study Start Date : January 2003
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2009

Group 1

Primary Outcome Measures :
  1. Help studies using dates and DNA collected to determine possible genetic factor. [ Time Frame: Ongoing ]

Biospecimen Retention:   Samples With DNA
DNA samples or blood or mouthwash were collected in veterans' homes by nurses.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Living veterans with an ALS diagnosis verified by medical records.

Inclusion Criteria:

Living veteran with ALS verified via medical record review.

Exclusion Criteria:

Veteran whose medial records did not verify an ALS diagnosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00076154

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United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
US Department of Veterans Affairs
ALS Association
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Study Chair: Eugene Z. Oddone, MD MHSc VA Medical Center

Additional Information:
Publications of Results:

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Responsible Party: US Department of Veterans Affairs Identifier: NCT00076154    
Other Study ID Numbers: 500A
First Posted: January 16, 2004    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: April 2014
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases