title: ALS Multicenter Cohort Study of Oxidative Stress (ALS COSMOS): study methodology, recruitment, and baseline demographic and disease characteristics.
abstract: Abstract In a multicenter study of newly diagnosed ALS patients without a reported family history of ALS, we are prospectively investigating whether markers of oxidative stress (OS) are associated with disease progression. Methods utilize an extensive structured telephone interview ascertaining environmental, lifestyle, dietary and psychological risk factors associated with OS. Detailed assessments were performed at baseline and at 3-6 month intervals during the ensuing 30 months. Our biorepository includes DNA, plasma, urine, and skin. Three hundred and fifty-five patients were recruited. Subjects were enrolled over a 36-month period at 16 sites. To meet the target number of subjects, the recruitment period was prolonged and additional sites were included. Results showed that demographic and disease characteristics were similar between 477 eligible/non-enrolled and enrolled patients, the only difference being type of health insurance among enrolled patients. Sites were divided into three groups by the number of enrolled subjects. Comparing these three groups, the Columbia site had fewer 'definite ALS' diagnoses. This is the first prospective, interdisciplinary, in-depth, multicenter epidemiological investigation of OS related to ALS progression and has been accomplished by an aggressive recruitment process. The baseline demographic and disease features of the study sample are now fully characterized.
authors.affiliation: Eleanor and Lou Gehrig MDA/ALS Research Center, Department of Neurology, Columbia University Medical Center , New York.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Mitsumoto
authors.forename: Pam
authors.initials: P
authors.lastname: Factor-Litvak
authors.forename: Howard
authors.initials: H
authors.lastname: Andrews
authors.forename: Raymond R
authors.initials: RR
authors.lastname: Goetz
authors.forename: Leslie
authors.initials: L
authors.lastname: Andrews
authors.forename: Judith G
authors.initials: JG
authors.lastname: Rabkin
authors.forename: Martin
authors.initials: M
authors.lastname: McElhiney
authors.forename: Jeri
authors.initials: J
authors.lastname: Nieves
authors.forename: Regina M
authors.initials: RM
authors.lastname: Santella
authors.forename: Jennifer
authors.initials: J
authors.lastname: Murphy
authors.forename: Jonathan
authors.initials: J
authors.lastname: Hupf
authors.forename: Jess
authors.initials: J
authors.lastname: Singleton
authors.forename: David
authors.initials: D
authors.lastname: Merle
authors.forename: Mary
authors.initials: M
authors.lastname: Kilty
authors.forename: Daragh
authors.initials: D
authors.lastname: Heitzman
authors.forename: Richard S
authors.initials: RS
authors.lastname: Bedlack
authors.forename: Robert G
authors.initials: RG
authors.lastname: Miller
authors.forename: Jonathan S
authors.initials: JS
authors.lastname: Katz
authors.forename: Dallas
authors.initials: D
authors.lastname: Forshew
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Barohn
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Sorenson
authors.forename: Bjorn
authors.initials: B
authors.lastname: Oskarsson
authors.forename: J Americo M
authors.initials: JA
authors.lastname: Fernandes Filho
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Kasarskis
authors.forename: Catherine
authors.initials: C
authors.lastname: Lomen-Hoerth
authors.forename: Tahseen
authors.initials: T
authors.lastname: Mozaffar
authors.forename: Yvonne D
authors.initials: YD
authors.lastname: Rollins
authors.forename: Sharon P
authors.initials: SP
authors.lastname: Nations
authors.forename: Andrea J
authors.initials: AJ
authors.lastname: Swenson
authors.forename: Jeremy M
authors.initials: JM
authors.lastname: Shefner
authors.forename: Jinsy A
authors.initials: JA
authors.lastname: Andrews
authors.forename: Boguslawa A
authors.initials: BA
authors.lastname: Koczon-Jaremko
mesh_terms: D000368:Aged; D000690:Amyotrophic Lateral Sclerosis / Q000453:epidemiology* / Q000235:genetics / Q000378:metabolism / Q000503:physiopathology*; D015331:Cohort Studies; D003710:Demography; D018450:Disease Progression; D005260:Female; D006801:Humans; D019458:Insurance Coverage / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D018384:Oxidative Stress / Q000502:physiology*; D018579:Patient Selection; D012867:Skin / Q000473:pathology; D011795:Surveys and Questionnaires; D013997:Time Factors; D014481:United States
keywords: ALS; disease progression; epidemiology; oxidative stress; survival