NCT00076154

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,121

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 14, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2004

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

4.7 years

First QC Date

January 14, 2004

Last Update Submit

April 18, 2014

Conditions

ALS

Keywords

ALS

Outcome Measures

Primary Outcomes (1)

  • Help studies using dates and DNA collected to determine possible genetic factor.

    Ongoing

Study Arms (1)

Group 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Living veterans with an ALS diagnosis verified by medical records.

You may qualify if:

  • Living veteran with ALS verified via medical record review.

You may not qualify if:

  • Veteran whose medial records did not verify an ALS diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (5)

  • 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.

    PMID: 18421219RESULT

  • 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. doi: 10.1159/000126910. Epub 2008 Apr 18.

    PMID: 18421218RESULT

  • Khishchenko 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.

    PMID: 19153849RESULT

  • Kasarkis 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.

    PMID: 15512895RESULT

  • Pastula 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.

    PMID: 19922120RESULT

Biospecimen

Retention: SAMPLES WITH DNA

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

Study Officials

  • Eugene Z. Oddone, MD MHSc

    VA Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2004

First Posted

January 16, 2004

Study Start

January 1, 2003

Primary Completion

September 1, 2007

Study Completion

September 1, 2009

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations

US(1)