The MURDOCK Study Community Registry and Biorepository Multiple Sclerosis Cohort

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01723709
First received: October 24, 2012
Last updated: July 22, 2016
Last verified: July 2016
  Purpose
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.

Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The MURDOCK Study Community Registry and Biorepository Multiple Sclerosis Cohort

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Serum-based proteomic biomarkers associated with disease initiation and progression in MS [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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
7.5 mL PaxGene RNA collection 6 mL DNA whole blood collection 40 mL urine collection 20 mL serum SST tube collection 16 mL plasma EDTA tube collection

Estimated Enrollment: 1000
Study Start Date: June 2010
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723709

Locations
United States, North Carolina
Carolinas Medical Center Northeast Medical Arts Building
Concord, North Carolina, United States, 28025
NorthEast Neurology - Concord
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
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Simon Gregory, PhD Duke Medicine Site Based Research Group
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01723709     History of Changes
Other Study ID Numbers: Pro00023791 
Study First Received: October 24, 2012
Last Updated: July 22, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
multiple sclerosis
immune response
genetic
progression
relapse
biomarkers
disease
proteomics
genome
gene

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 24, 2016