Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007722
Status:
COMPLETED
Last Update Posted:
2009-10-09
First Post:
2000-12-29
Brief Title:
Amyotrophic Lateral Sclerosis ALS Gulf War Study
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 500 - An Epidemiological Investigation Into the Occurrence of Amyotrophic Lateral Sclerosis ALS Among Gulf War Veterans
Status:
COMPLETED
Status Verified Date:
2009-10
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:
None
Brief Summary:
Recently concern has arisen regarding a possible elevated occurrence of ALS among veterans who served in the Persian Gulf during Operations Desert Shield August 2 1990 - January 15 1991 Desert Storm January 16 1991 - February 28 1991 and Clean-up March 1 1991 - July 31 1991 This study involves an epidemiologic investigation into the occurrence of ALS among veterans of the Gulf War This study will further define the epidemiology of this neurological disease among younger individuals while determining whether there is a higher than expected occurrence It will also ascertain the etiologic importance of deployment to the Persian Gulf and exposure to specific environmental factors in that geographic area VA is leading this joint federal government epidemiologic study that also involves DoD HHS CDC and academic centers of excellence in neurology with advice from the ALS Association
Detailed Description:
Primary Objectives To develop through nationwide ascertainment a comprehensive descriptive epidemiology of amyotrophic lateral sclerosis ALS among Gulf War veterans with particular attention to whether there is a higher than expected occurrence of ALS among deployed veterans as compared to non-deployed Gulf War veterans
Secondary Objectives To ascertain probablepossible etiologic factors with particular focus on the role of chemical or biologic factors in the Persian Gulf area of deployment
Primary Outcomes Incidence of ALS among deployed and non-deployed veterans of the Gulf War
Intervention NA
Study Abstract Recently concern has arisen regarding a possible elevated occurrence of ALS among veterans who served in the Persian Gulf during Operations Desert Shield August 2 1990 - January 15 1991 Desert Storm January 16 1991 - February 28 1991 and Clean-up March 1 1991 - July 31 1991 In response to this concern a nationwide epidemiological investigation was conducted to ascertain all occurrences of ALS between August 1990 and July 2000 among all active duty military and mobilized Reserves including National Guard who served during the Gulf War period August 2 1990-July 31 1991 A diagnosis of ALS was confirmed by medical record review and as necessary neurological examination Risk was assessed by the age-adjusted average annual 10-year cumulative incidence rate VA led this joint federal government epidemiologic study that also involved DoD HHS CDC and academic centers of excellence in neurology with advice from the ALS Association
The study population was defined as all active duty military and mobilized reserves and National Guard who served for at least one month at any time during the Gulf War period Mobilized reservists and members of the National Guard were those who were activated and called-up being either deployed to SW Asia or back-filling positions of military personnel who were deployed Deployed military personnel were those who served in the SW Asian theater during Operations Desert Shield and Desert Storm or the period immediately after Desert Storm or received hazardous duty pay during the Gulf War All other individuals in the study population were classified as non-deployed although they may have been stationed outside the US
This study has as its primary component a field epidemiological investigation involving nationwide ascertainment of ALS cases among deployed and non-deployed veterans of the Gulf War to obtain a census of ALS cases among these populations Ascertainment of cases occurred through three avenues The first was a search of extant VA and DoD medical databases Second we solicited cases from the ALS Association other related organizations and from VA and DoD neurology clinics And third we identified cases through self-referrals that resulted from national media announcements Purported cases were verified via medical record review and as necessary a detailed clinical examination For all living cases we are collecting a sample of blood and urine for determination of ALS-relevant DNA mutations and heavy metal exposure respectively There is also an in-home visit that includes an interview of the patient and family members with emphasis on ascertainment of unique exposures
Results In this large epidemiological study researchers supported by both the Department of VA and DoD have found preliminary evidence that veterans who served in Desert Shield-Desert Storm are nearly twice as likely as their non-deployed counterparts to develop ALS VA is exploring options for compensating veterans who served in the Gulf and who subsequently develop ALS
Ongoing Surveillance The study team has implemented an ongoing surveillance system to detect future cases of ALS that develop in this veteran population This system involves maintaining the linkages created to detect current cases New cases will be subject to the same protocols for verification enrollment and data collection as in the original case ascertainment study
Secondary Objectives To ascertain probablepossible etiologic factors with particular focus on the role of chemical or biologic factors in the Persian Gulf area of deployment
Primary Outcomes Incidence of ALS among deployed and non-deployed veterans of the Gulf War
Intervention NA
Study Abstract Recently concern has arisen regarding a possible elevated occurrence of ALS among veterans who served in the Persian Gulf during Operations Desert Shield August 2 1990 - January 15 1991 Desert Storm January 16 1991 - February 28 1991 and Clean-up March 1 1991 - July 31 1991 In response to this concern a nationwide epidemiological investigation was conducted to ascertain all occurrences of ALS between August 1990 and July 2000 among all active duty military and mobilized Reserves including National Guard who served during the Gulf War period August 2 1990-July 31 1991 A diagnosis of ALS was confirmed by medical record review and as necessary neurological examination Risk was assessed by the age-adjusted average annual 10-year cumulative incidence rate VA led this joint federal government epidemiologic study that also involved DoD HHS CDC and academic centers of excellence in neurology with advice from the ALS Association
The study population was defined as all active duty military and mobilized reserves and National Guard who served for at least one month at any time during the Gulf War period Mobilized reservists and members of the National Guard were those who were activated and called-up being either deployed to SW Asia or back-filling positions of military personnel who were deployed Deployed military personnel were those who served in the SW Asian theater during Operations Desert Shield and Desert Storm or the period immediately after Desert Storm or received hazardous duty pay during the Gulf War All other individuals in the study population were classified as non-deployed although they may have been stationed outside the US
This study has as its primary component a field epidemiological investigation involving nationwide ascertainment of ALS cases among deployed and non-deployed veterans of the Gulf War to obtain a census of ALS cases among these populations Ascertainment of cases occurred through three avenues The first was a search of extant VA and DoD medical databases Second we solicited cases from the ALS Association other related organizations and from VA and DoD neurology clinics And third we identified cases through self-referrals that resulted from national media announcements Purported cases were verified via medical record review and as necessary a detailed clinical examination For all living cases we are collecting a sample of blood and urine for determination of ALS-relevant DNA mutations and heavy metal exposure respectively There is also an in-home visit that includes an interview of the patient and family members with emphasis on ascertainment of unique exposures
Results In this large epidemiological study researchers supported by both the Department of VA and DoD have found preliminary evidence that veterans who served in Desert Shield-Desert Storm are nearly twice as likely as their non-deployed counterparts to develop ALS VA is exploring options for compensating veterans who served in the Gulf and who subsequently develop ALS
Ongoing Surveillance The study team has implemented an ongoing surveillance system to detect future cases of ALS that develop in this veteran population This system involves maintaining the linkages created to detect current cases New cases will be subject to the same protocols for verification enrollment and data collection as in the original case ascertainment study
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