Serial Collection of Primary Progressive Multiple Sclerosis Participants in the MURDOCK Study

Study Description

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Brief Summary:

The goal of this study is to enroll 100 participants with Primary Progressive Multiple Sclerosis (PPMS) that have joined the MURDOCK Study Horizon 1.5 (Duke IRB Pro00011196) and the Multiple Sclerosis cohort (Duke IRB Pro00023791). All 100 participants will complete a biannual collection of a follow up questionnaire and blood/urine collection for a period of 5 years.

Condition or disease	Intervention/treatment
Primary Progressive Multiple Sclerosis	Other: generation of 'omic markers of disease progression

Detailed Description:

Unlike Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary Progressive Multiple Sclerosis (SPMS) in which patients experience a remission or lessening of their symptoms, Primary Progressive Multiple Sclerosis (PPMS) is characterized by progression of disability from onset, with no, or only occasional and minor, remissions and improvements. The age of onset for the primary progressive subtype is later than for the relapsing-remitting, but similar to mean the age of progression between the relapsing-remitting and the secondary progressive - around 40 years of age. Because of its prevalence, RRMS represents the largest basis for basic and clinical MS research. Therefore, drugs have primarily been developed to slow disease progression in RRMS and SPMS patients. No treatment has been proven successful in treating primary progressive MS.

The MURDOCK-MS collection represents a unique opportunity to carry out detailed biomarker research on PPMS patients and, to the knowledge of this investigator and his colleagues in the field, would represent an exceptional cohort that is not available elsewhere in the US or the rest of the world. Aside from first in disease sampling, the serial, biannual collection of samples from PPMS patients would not only permit the identification of 'omic profiles that can be compared and contrasted to those from RRMS patients in a parallel study, but it would also allow the generation of 'omic markers of disease progression. This progressive etiology would provide valuable insight into PPMS development and may also shed light on SPMS progression.

Study Design

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Study Type :	Observational
Estimated Enrollment :	100 participants
Observational Model:	Cohort
Time Perspective:	Other
Official Title:	Serial Collection of Primary Progressive Multiple Sclerosis Participants in the MURDOCK Study
Study Start Date :	January 2013
Estimated Primary Completion Date :	February 2020
Estimated Study Completion Date :	February 2020

Groups and Cohorts

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Intervention Details:

Other: generation of 'omic markers of disease progression
Aside from first in disease sampling, the serial, biannual collection of samples from PPMS patients would not only permit the identification of 'omic profiles that can be compared and contrasted to those from RRMS patients in a parallel study, but it would also allow the generation of 'omic markers of disease progression.

Outcome Measures

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Primary Outcome Measures :

1. Generation of 'omic markers of disease progression [ Time Frame: 5 years ]
   Biannual collection of samples from PPMS patients would not only permit the identification of 'omic profiles that can be compared and contrasted to those from RRMS patients in a parallel study, but it would also allow the generation of 'omic markers of disease progression. This progressive etiology would provide valuable insight into PPMS development and may also shed light on SPMS progression.

Biospecimen Retention:   Samples With DNA

Blood (RNA/DNA), serum, plasma, urine

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 100 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Participants must enroll in the MURDOCK Study Horizon 1.5 (Pro00011196) as well as the Multiple Sclerosis cohort (Pro00023791) in order to participate in this biannual collection of a follow up questionnaire and blood/urine collection for participants who have Primary Progressive MS. The biannual collection will continue for 5 years. Those participants with PPMS who are already enrolled in the MURDOCK Study Horizon 1.5 and Multiple Sclerosis cohort will be contacted via phone to assess interest in the PPMS study. New participants with PPMS who enroll into the Horizon 1.5 study and Multiple Sclerosis cohort will be asked during the time of enrollment if they would like to participate in the PPMS study as well.

Criteria

Inclusion Criteria:

• Enrolled in the MURDOCK Study Horizon 1.5 (Pro00011196)
• Enrolled in the Multiple Sclerosis Cohort (Pro00023791)
• Diagnosed with Primary Progressive Multiple Sclerosis
• At least 18 years of age

Exclusion Criteria:

• Participants not willing to participate or sign informed consent

Contacts and Locations

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Locations

United States, North Carolina
NE Neurology
Concord, North Carolina, United States, 28025
The Stedman Center on the Duke Center for Living Campus
Durham, North Carolina, United States, 27705
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:	Simon Gr, PhD	Duke Medicine Site Based Research Group

More Information

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Additional Information:

Related Info 

Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT01776060 History of Changes
Other Study ID Numbers:	Pro00040961
First Posted:	January 25, 2013
Last Update Posted:	February 12, 2018
Last Verified:	February 2018

Keywords provided by Duke University:

Primary Progressive Multiple Sclerosis; Multiple Sclerosis; biomarker; 'omic; progression

Additional relevant MeSH terms:

Sclerosis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS	Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases