National Registry of Veterans With Amyotrophic Lateral Sclerosis and DNA Bank (ALS Registry)

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ClinicalTrials.gov Identifier: NCT00076154

Recruitment Status : Completed

First Posted : January 16, 2004

Last Update Posted : April 21, 2014

Sponsor:

Collaborator:

ALS Association

Information provided by (Responsible Party):

VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description

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
ALS

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.

Study Design


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

Genetic and Rare Diseases Information Center resources: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Group 1

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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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.

Criteria

Inclusion Criteria:

Living veteran with ALS verified via medical record review.

Exclusion Criteria:

Veteran whose medial records did not verify an ALS diagnosis.

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00076154

Locations


United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705

Sponsors and Collaborators

US Department of Veterans Affairs

ALS Association

Investigators


Study Chair:	Eugene Z. Oddone, MD MHSc	VA Medical Center

More Information

Publications of Results:

Schmidt S, Allen KD, Loiacono VT, Norman B, Stanwyck CL, Nord KM, Williams CD, Kasarskis EJ, Kamel F, McGuire V, Nelson LM, Oddone EZ. Genes and Environmental Exposures in Veterans with Amyotrophic Lateral Sclerosis: the GENEVA study. Rationale, study design and demographic characteristics. Neuroepidemiology. 2008;30(3):191-204. doi: 10.1159/000126911. Epub 2008 Apr 18.

Allen KD, Kasarskis EJ, Bedlack RS, Rozear MP, Morgenlander JC, Sabet A, Sams L, Lindquist JH, Harrelson ML, Coffman CJ, Oddone EZ. The National Registry of Veterans with amyotrophic lateral sclerosis. Neuroepidemiology. 2008;30(3):180-90. doi: 10.1159/000126910. Epub 2008 Apr 18.

Khishchenko N, Allen KD, Coffman CJ, Kasarskis EJ, Lindquist JH, Morgenlander JC, Norman BB, Oddone EZ, Rozear MP, Sabet A, Sams L, Bedlack RS. Time to diagnosis in the National Registry of Veterans with Amyotrophic Lateral Sclerosis. Amyotroph Lateral Scler. 2010;11(1-2):125-32. doi: 10.3109/17482960802572681.

Kasarkis EJ, Dominic K, Oddone EZ. The National Registry of Veterans with Amyotrophic Lateral Sclerosis: Department of Veterans Affairs Cooperative Studies Program (CSP) #500a. Amyotroph Lateral Scler Other Motor Neuron Disord. 2004 Sep;5 Suppl 1:129-32.

Pastula DM, Coffman CJ, Allen KD, Oddone EZ, Kasarskis EJ, Lindquist JH, Morgenlander JC, Norman BB, Rozear MP, Sams LA, Sabet A, Bedlack RS. Factors associated with survival in the National Registry of Veterans with ALS. Amyotroph Lateral Scler. 2009 Oct-Dec;10(5-6):332-8. doi: 10.3109/17482960802320545.


Responsible Party:	US Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00076154 History of Changes
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 ):


ALS

Additional relevant MeSH terms:


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

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