Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076154
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2004-01-14
Brief Title:
National Registry of Veterans With Amyotrophic Lateral Sclerosis and DNA Bank
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 500A - National Registry of Veterans With Amyotrophic Lateral Sclerosis
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALS Registry
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
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 causes 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 NA
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 andor access to Registry participants
Results NA
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
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 NA
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 andor access to Registry participants
Results NA
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None