The MURDOCK Study Community Registry and Biorepository Multiple Sclerosis Cohort
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01723709|
Recruitment Status : Completed
First Posted : November 8, 2012
Last Update Posted : July 21, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||973 participants|
|Official Title:||The MURDOCK Study Community Registry and Biorepository Multiple Sclerosis Cohort|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
- Serum-based proteomic biomarkers associated with disease initiation and progression in MS [ Time Frame: 5 years ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723709
|United States, North Carolina|
|Carolinas Medical Center Northeast Medical Arts Building|
|Concord, North Carolina, United States, 28025|
|Ada Jenkins Center|
|Davidson, North Carolina, United States, 28036|
|The Stedman Center on the Duke Center for Living Campus|
|Durham, North Carolina, United States, 27705|
|Kannapolis Internal Medicine|
|Kannapolis, North Carolina, United States, 28081|
|Raleigh Neurology Associates|
|Raleigh, North Carolina, United States, 27607|
|Principal Investigator:||Simon Gregory, PhD||Duke Medicine Site Based Research Group|