Clinical trial NCT01723709: The MURDOCK Study Community Registry and Biorepository Multiple Sclerosis Cohort
Official title: The MURDOCK Study Community Registry and Biorepository Multiple Sclerosis Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
immune response
genetic
progression
relapse
biomarkers
disease
proteomics
genome
gene
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2012-11-08
Enrollment: 973
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants must enroll or have enrolled in the MURDOCK Study Community Registry and Biorepository prior to joining the Multiple Sclerosis Cohort. At the MURDOCK Study visit, or after the participant has enrolled in the MURDOCK Study, they will be asked (either in person or via the phone) if they would be willing to join the Multiple Sclerosis cohort study.

Brief summary: The goal of this study is to enroll 1000 participants with a history of Multiple Sclerosis into the MURDOCK Study (Duke IRB Pro00011196) as well as into the Multiple Sclerosis Cohort study (Duke IRB Pro00023791). All 1000 participants will answer a 4-page questionnaire administered by a trained study coordinator which is designed to collect information on the participant's diagnosis of Multiple Sclerosis. The goal of the study is to seek genetic explanations for response to treatment, progression of the disease, and biomarker validation.

Detailed description: Despite tremendous research efforts, the targets of immune response and the mechanisms for neuronal loss associated with MS have not been fully characterized. Although substantial advances have been made in the development of therapeutic treatments, the drugs currently available to MS patients do not significantly alter the long-term prognosis of the disease. Better markers that represent the biological activity of the disease process and response to therapy are desperately needed. MS is thought to be mediated by autoimmunity which causes demyelination and transection of axons throughout the brain and spinal cord resulting in the formation of multiple scars (or scleroses) on axon myelin sheaths and reducing electrical conductivity and decreased CNS signaling. It is most common in young adults; more than 90% of patients are diagnosed before the age of 55 and less than 5% before the age of 14. Females are 2-3 times more frequently affected than males and children of affected females are at a significantly higher risk of developing MS than children of affected males. A strong genetic component is suggested by the co-occurrence of cases within families and the high disease prevalence in some ethnic populations (particularly those of northern European origin) compared with others (African and Asian groups) irrespective of geographic location.7 The incidence of MS in northern Europe, where the genetically associated haplotype HLA DR2 is most common, is as high as 1 per 750 individuals. MS affects more than 400,000 people in the U.S. and 2.5 million worldwide.

Although numerous putative MS-specific biomarkers, representing different mechanisms of pathogenesis and steps along the inflammatory cascade have been proposed, none have been fully validated. To date, the majority of studies identifying biomarkers associated with MS initiation or progression have been limited to investigation of one to several markers at a time; only one study has attempted open platform proteomic profiling in MS; however, the study size was relatively small and the clinical homogeneity of the dataset of the study is not clear. To understand a complex disease like MS, high throughput technologies capable of profiling multiple etiological changes is needed as well as a well-define population of those with the disease.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Multiple Sclerosis Diagnosis or self report Multiple Sclerosis

Exclusion Criteria:

* Participants who are not willing to participate in this study

Primary outcomes:
measure: Serum-based proteomic biomarkers associated with disease initiation and progression in MS
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: United States
facility: Carolinas Medical Center Northeast Medical Arts Building
state: North Carolina
city: Davidson
country: United States
facility: Ada Jenkins Center
state: North Carolina
city: Durham
country: United States
facility: The Stedman Center on the Duke Center for Living Campus
state: North Carolina
city: Kannapolis
country: United States
facility: Kannapolis Internal Medicine
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
Study officials:
affiliation: Duke Medicine Site Based Research Group
name: Simon Gregory, PhD
role: PRINCIPAL_INVESTIGATOR
References: