The MURDOCK Study Community Registry and Biorepository Multiple Sclerosis Cohort

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01723709
First received: October 24, 2012
Last updated: September 8, 2014
Last verified: September 2014
  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: After enrollment is complete ] [ 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: June 2016
Estimated Primary Completion Date: June 2016 (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
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

Contacts
Contact: Kimberly Roseman 704-250-5861 kimberly.roseman@duke.edu
Contact: Sarah Maichle 919-695-6413 sarah.maichle@duke.edu

Locations
United States, North Carolina
Charlotte Neuroscience and Spine Institute Recruiting
Charlotte, North Carolina, United States, 28205
Contact: Bridget Loven    704-446-1987    bridget.loven@carolinashealthcare.org   
Principal Investigator: Jill Conway, M.D.         
NorthEast Neurology - Concord Recruiting
Concord, North Carolina, United States, 28025
Contact: Kimberly Roseman    704-250-5861    kimberly.roseman@duke.edu   
Contact: Leah Bouk    919-451-5051    leah.bouk@duke.edu   
Principal Investigator: Simon Gregory, PhD         
Carolinas Medical Center Northeast Medical Arts Building Recruiting
Concord, North Carolina, United States, 28025
Contact: Kimberly Roseman    704-250-5861    kimberly.roseman@duke.edu   
Contact: Leah Bouk    919-451-5051    leah.bouk@duke.edu   
Principal Investigator: Simon Gregory, PhD         
Ada Jenkins Center Recruiting
Davidson, North Carolina, United States, 28036
Contact: Kimberly Roseman    704-250-5861    kimberly.roseman@duke.edu   
Contact: Leah Bouk    919-451-5051      
Principal Investigator: Simon Gregory, PhD         
Duke Center for Human Genetics Recruiting
Durham, North Carolina, United States, 27705
Contact: Sarah M Maichle    919-695-6413    sarah.maichle@duke.edu   
Principal Investigator: Simon Gregory, PhD         
Kannapolis Internal Medicine Recruiting
Kannapolis, North Carolina, United States, 28081
Contact: Kimberly Roseman    704-250-5861    kimberly.roseman@duke.edu   
Contact: Leah Bouk    919-451-5051    leah.bouk@duke.edu   
Principal Investigator: Simon Gregory, PhD         
Raleigh Neurology Associates Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Beth Jackson    919-719-8826    bjackson@raleighneurology.com   
Contact: Nicole Dixon    919-719-8826    ndixon@raleighneurology.com   
Principal Investigator: Simon Gregory, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Simon Gregory, PhD Duke Medicine Site Based Research Group
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01723709     History of Changes
Other Study ID Numbers: Pro00023791
Study First Received: October 24, 2012
Last Updated: September 8, 2014
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:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014