ALSALS RegistryNCT00076154
National Registry of Veterans With Amyotrophic Lateral Sclerosis and DNA Bank
An observational study of ALS, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ALS
- How many people
- 2,121 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Living veterans with an ALS diagnosis verified by medical records.
Who may be able to join
- Living veteran with ALS verified via medical record review.
Who cannot join
- Veteran whose medial records did not verify an ALS diagnosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center
Durham, North Carolina, 27705
About this study
Official title: CSP #500A - National Registry of Veterans With Amyotrophic Lateral Sclerosis
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.
Read the 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.
- Conditions
- ALS
- Keywords
- ALS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Help studies using dates and DNA collected to determine possible genetic factor.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2004 (estimated)
- Study startJan 2003
- Primary completionSep 2007
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ALSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,121 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- ALS Association
- Responsible party
- Sponsor
- Investigators
- Eugene Z. Oddone, MD MHSc, Study chair, VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076154
- Sponsor's protocol ID
- 500A
- Acronym
- ALS Registry
- Status last verified
- Apr 2014
- First submitted
- 14 Jan 2004
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18421219Allen 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.
PubMed 18421218Khishchenko 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.
PubMed 19153849Kasarkis 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. doi: 10.1080/17434470410019915.
PubMed 15512895Pastula 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.
PubMed 19922120
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #500A - National Registry of Veterans With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT00076154
- Acronym / sponsor ID
- ALS Registry / 500A
- Conditions
- ALS
- Keywords
- ALS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,121 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- ALS Association
- Study start
- Jan 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Living veterans with an ALS diagnosis verified by medical records.
Key inclusion criteria (1 listed)
- Living veteran with ALS verified via medical record review.
Key exclusion criteria (1 listed)
- Veteran whose medial records did not verify an ALS diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Help studies using dates and DNA collected to determine possible genetic factor.
Time frame: Ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Results publication: PubMed 18421219Schmidt 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.
- Results publication: PubMed 18421218Allen 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.
- Results publication: PubMed 19153849Khishchenko 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.
- Results publication: PubMed 15512895Kasarkis 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. doi: 10.1080/17434470410019915.
- Results publication: PubMed 19922120Pastula 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Z. Oddone, MD MHSc study chair
VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Help studies using dates and DNA collected to determine possible genetic factor. (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00076154, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.