This study is currently recruiting patients.
Verified by Department of Veterans Affairs January 2004
Sponsors and Collaborators: Department of Veterans Affairs
ALS Association
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00076154
Purpose
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
ALS
MedlinePlus related topics: Amyotrophic Lateral Sclerosis
Genetics Home Reference related topics: amyotrophic lateral sclerosis
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study
Official Title: CSP #500A - National Registry of Veterans With Amyotrophic Lateral Sclerosis
Further study details as provided by Department of Veterans Affairs:
Expected Total Enrollment: 1840
Study start: January 2003
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.
Eligibility
Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
* Living veteran with ALS verified via medical record review.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00076154
North Carolina
Durham VAMC, Durham, North Carolina, 27705, United States; Recruiting
Eugene Z Oddone, MD, MHSc 919-286-6936 oddon001@...
More Information
Study ID Numbers: 500A
Last Updated: January 12, 2006
Record first received: January 14, 2004
ClinicalTrials.gov Identifier: NCT00076154
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-07-10
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Group home page: http://groups.yahoo.com/group/Vets_ALS
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