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

This study has been completed.
Sponsor:
Collaborator:
ALS Association
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00076154
First received: January 14, 2004
Last updated: April 18, 2014
Last verified: April 2014
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: CSP #500A - National Registry of Veterans With Amyotrophic Lateral Sclerosis

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Help studies using dates and DNA collected to determine possible genetic factor. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA samples or blood or mouthwash were collected in veterans' homes by nurses.


Enrollment: 2121
Study Start Date: January 2003
Study Completion Date: September 2009
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

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.

  Eligibility

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076154

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

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00076154     History of Changes
Other Study ID Numbers: 500A
Study First Received: January 14, 2004
Last Updated: April 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
ALS

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014