The MURDOCK Study Community Registry and Biorepository Multiple Sclerosis Cohort

NCT01723709 | Completed DMC

• 1 other identifier: Pro00023791
• Study Type: observational
• Target: 973
• Locations: 1 country
• Sites: 5

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; immune response; genetic; progression; relapse; biomarkers; disease; proteomics; genome; gene

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years of age or older
• Multiple Sclerosis Diagnosis or self report Multiple Sclerosis

You may not qualify if:

• Participants who are not willing to participate in this study

Sponsors & Collaborators

• Duke University: lead

Study Sites (5)

Carolinas Medical Center Northeast Medical Arts Building

Concord, North Carolina, 28025, United States

Location

Ada Jenkins Center

Davidson, North Carolina, 28036, United States

Location

The Stedman Center on the Duke Center for Living Campus

Durham, North Carolina, 27705, United States

Location

Kannapolis Internal Medicine

Kannapolis, North Carolina, 28081, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

Location

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

MeSH Terms

Conditions

Multiple Sclerosis; Disease Progression; Recurrence; Disease

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Gregory, PhD

  Duke Medicine Site Based Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: November 8, 2012
• Study Start: June 1, 2010
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-06

Locations

US (5)