The MURDOCK Study Community Registry and Biorepository Multiple Sclerosis Cohort

Multiple Sclerosis Clinical Trial

Official title:

The MURDOCK Study Community Registry and Biorepository Multiple Sclerosis Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723709
• Other study ID #: Pro00023791
• Status: Completed
• Phase: N/A
• First received: October 24, 2012
• Last updated: July 18, 2017
• Start date: June 2010
• Est. completion date: May 2017

Study information

• Verified date: June 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 973
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Carolinas Medical Center Northeast Medical Arts Building	Concord	North Carolina
United States	Ada Jenkins Center	Davidson	North Carolina
United States	The Stedman Center on the Duke Center for Living Campus	Durham	North Carolina
United States	Kannapolis Internal Medicine	Kannapolis	North Carolina
United States	Raleigh Neurology Associates	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum-based proteomic biomarkers associated with disease initiation and progression in MS	Biological material (serum, urine, whole blood and Paxgene RNA) collected in the MURDOCK Study(Pro00011196) will permit the initiation of a biomarker discovery project for all patients consented under the MS cohort protocol. Participants in this study will be followed for 5 years after consent with additional blood draws and questionnaires occurring biannually during this period.	5 years