CSP #500-A Main study & Related studies (2) - VA Cooperative Studies Program (CSP)
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VA Cooperative Studies Program (CSP)

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CSP #500-A Main study & Related studies (2)

Main study:
CSP #500-A: A National Registry of Veterans with Amyotrophic Lateral Sclerosis (ALS) 

Related studies:
CSP #500-A-Sub-Study: A National Registry of Veterans with Amyotrophic Lateral Sclerosis (ALS): DNA Bank 
CSP #500-B: Genetic Epidemiology of ALS in Veterans (GENEVA) 

Data Sharing Statement

What's available

  • Research data: Individual participant data collected for the main study and two related studies, after deidentification. Data are available in SAS and text files.
  • Biospecimens: Coded DNA collected from 1,225 consenting participants 

Available Documentation 

Study forms (PDF format) 

Dates Data are Available 

Currently available, no end date 

Access Criteria

Investigators associated with VA or non-VA nonprofit, academic, or research institutions are invited to submit data and specimen requests to Kellie.Sims@va.gov. Requests with IRB-approved protocols will be reviewed for scientific and ethical merit. Requestors must be fully compliant with VA data security, privacy and human subjects requirements. This may involve implementation of access agreements (e.g., data use agreement). Allowable analyses include those designed to achieve the aims in the approved proposal submitted to the review committee. 

Interested investigators are encouraged to contact Kellie.Sims@va.gov to arrange a consultation during study planning to discuss the proposed study and data/biospecimen access requirements.  

Study Characteristics:
CSP #500-A: A National Registry of Veterans with Amyotrophic Lateral Sclerosis (ALS) 
CSP #500-A-Sub-Study: A National Registry of Veterans with ALS: DNA Bank 

Objectives

CSP #500-A: To identify living Veterans with ALS, track the progression of their disease, and serve as a vehicle to facilitate study of epidemiological risk factors for ALS in a military context
CSP #500-A-Sub-study (DNA Bank): To develop a DNA bank for Veterans included in the ALS Registry which will be available for approved studies examining the cause(s) of ALS

Era of Service

All

Population

Veterans with a verified diagnosis of ALS regardless of VA user status in 2003-2007

Study Design 

Prospective case-only

Time Period 

2003 - 2007

Setting

National

CSP #500-A: 2,121
CSP #500-A-Sub-study (DNA Bank): 1,225 biospecimens  

Response Rate

N/A

Recruitment Method

Participants were identified from VA medical databases and nationwide publicity efforts, including advertisements to ALS, Veteran Service Organizations (VSO), and other groups. Participants were recruited by phone.

Compensation

None

Data Collected

CSP #500-A: Interview data, including ALS Functional Rating Scale scores
CSP #500-A-Sub-study (DNA Bank): Blood specimen (40-ml) or buccal cell sample  

Data Collection Method

CSP #500-A: Phone interviews completed at 6-month intervals with the Veteran or a proxy
CSP #500-A-Sub-study (DNA Bank): DNA samples from blood or mouthwash were collected in Veterans' homes by nurses 

Funding Source

VA Cooperative Studies Program (CSP)

Contact 

Kellie.Sims@va.gov

Selected Publications 

DiMartino L, Allen KD, Kasarskis E, Lindquist JH, Coffman CJ, Oddone EZ; National Registry of Veterans with ALS. Characteristics associated with participation in DNA banking: The National Registry of Veterans with ALS. Contemp Clin Trials. 2007 Sep;28(5):572-82.

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.

Horner RD, Grambow SC, Coffman CJ, Lindquist JH, Oddone EZ, Allen KD, Kasarskis EJ. Amyotrophic lateral sclerosis among 1991 Gulf War Veterans: evidence for a time-limited outbreak. Neuroepidemiology. 2008;31(1):28-32. 

Kasarskis EJ, Lindquist JH, Coffman CJ, Grambow SC, Feussner JR, Allen KD, Oddone EZ, Kamins KA, Horner RD; ALS Gulf War Clinical Review Team. Clinical Aspects of ALS in Gulf War Veterans. Amyotroph Lateral Scler. 2009 Feb;10(1):35-41.  

More Information 

Main study and related studies website
Main study ClinicalTrials.gov site
ClinicalTrials.gov Identifier: NCT00076154  



 

Study Characteristics:
CSP #500-B: Genetic Epidemiology of ALS in Veterans (GENEVA)

Objectives

To identify the genetic factors and environmental exposures that influence the development of ALS in the Veteran population

Era of Service

All

Population

Cases: Living enrollees in the National Registry of Veterans with ALS (NRVA) who were classified as having clinically definite ALS, clinically probable ALS, clinically probable and lab supported ALS, or clinically possible ALS, progressive muscular atrophy (PMA) or progressive bulbar palsy (PBP)
Controls: U.S. Veterans matched to cases on age, sex, race/ethnicity, and VA user status

Study Design 

Case-Control

Time Period 

2003 - 2007

Setting

National

Cases: 1,163
Controls: 411  

Response Rate

Pending

Recruitment Method

Cases: Veterans were identified from NRVA; those who had consented to participate in the DNA bank were recruited into the study
Controls: Veterans were identified from Veterans Benefit Administration databases; recruitment involved mailing an invitation letter, up to three reminder letters, and telephone follow-up 

Compensation

None

Data Collected

  • Study questionnaire collected information on demographics, military service characteristics, and environmental exposures (e.g., occupational history, pesticide use, consumption of tobacco, alcohol, and caffeinated drinks, deployment history, potential lead exposure)
  • DNA via blood or saliva samples

Data Collection Methods

Environmental exposure data were collected by structured telephone interview

For cases: DNA samples were obtained from the NRVA DNA bank
For controls: DNA samples were collected via mail using the Oragene saliva collection kit (DNA Genotek Inc., Ottawa, Ont., Canada)

Funding Sources

VA Cooperative Studies Program (CSP) with support from National Institute of Environmental Health Sciences/National Institutes of Health [R01 ES013244] and the ALS Association [ALSA 1230]

Contact 

Kellie.Sims@va.gov

Selected Publications 

Schmidt S, Allen K, Loiacono, V, Norman B, Stanwyck CL, Nord KM, Williams CD, Kasarskis EJ, Kamel F, McGuire V, Nelson LM, Oddone EZ, VA ALS Registry Group. Genes and Environmental Exposures in Veterans with Amyotrophic Lateral Sclerosis: The GENEVA Study. Neuroepidemiology. 2008 May; 30(3): 191–204.

Fang D, Kwee LC, Allen KD, Umbach DM, Ye W, Watson M, Keller J, Oddone EZ, Sandler DP, Schmidt S, Kamel F. Association between blood lead and the risk of amyotrophic lateral sclerosis. Am J Epidemiol. 2010 March 8;171:1126-1133.

Schmidt S, Kwee LC, Allen KD, Oddone EZ. Association of ALS with head injury, cigarette smoking and APOE genotypes. Journal of the Neurological Sciences. 2010;291:22-29. 

Kwee LC, Liu Y, Haynes C, Gibson JR, Stone A, Schichman SA, Kamel F, Nelson LM, Topol B, Van den Eeden SK, Tanner CM, Cudkowicz ME, Grasso DL, Lawson R, Muralidhar S, Oddone EZ, Schmidt S, Hauser MA. A high-density genome-wide association screen of sporadic ALS in US veterans. PLoS One. 2012;7(3):e32768.

More Information 

Main study and related studies website