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Comparison Between Clinical and MRI Multiple Sclerosis Activity and Expression of Human Endogenous Retrovirus Type W and Herpesvirus

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ClinicalTrials.gov Identifier: NCT02489877
Recruitment Status : Unknown
Verified July 2015 by Guilherme Sciascia do Olival, Faculdade de Ciências Médicas da Santa Casa de São Paulo.
Recruitment status was:  Not yet recruiting
First Posted : July 3, 2015
Last Update Posted : July 3, 2015
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Guilherme Sciascia do Olival, Faculdade de Ciências Médicas da Santa Casa de São Paulo

Brief Summary:
Multiple sclerosis is the most common autoimmune inflammatory disease of the central nervous system. It is known that your etiology has genetic and environmental causes. Several viruses have been implicated as triggers as well as perpetrators of this disease. Several studies make the correlation between Endogenous Retrovirus Type W (HERV-W) and the family Herpesviridae and activity in the pathogenesis of multiple sclerosis. The most important characteristics of the virus implicated in the pathogenesis of the disease is the fact that they have latency periods of exacerbation and they have, as their main biological environment, the central nervous system. The HERV-W, Epstein-Barr virus (EBV), cytomegalovirus, herpes virus type 6 and type 7 herpesvirus members are the most studied as causes of multiple sclerosis. It was found that these viruses are closely involved in the pathogenesis of MS, but it is believed that aren't the only responsible for its beginning. It is likely that this disease presents numerous triggers and more studies are needed to determine these interactions. In addition, a study comparing the activity of multiple sclerosis with the presence of these viruses was never realized.

Condition or disease
Multiple Sclerosis

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 84 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison Between Clinical and MRI Multiple Sclerosis Activity and Expression of Human Endogenous Retrovirus Type W and Herpesvirus in Peripheral Blood of Patients
Study Start Date : July 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Multiple Sclerosis
Patients diagnosed with Multiple Sclerosis
without Multiple Sclerosis
Healthy individuals without neurological disease associated
with other neurological diseases
Patients diagnosed with the following diseases: Lateral Amniotrofic Sclerosis, Headache , Parkinson's disease, Dementia and Epilepsy.



Primary Outcome Measures :
  1. Composite: Degree of disease activity [ Time Frame: 1 year ]
    The degree of disease activity will be a composite of clinical and imaging measures. Clinical measures will be analyzed by annualized rate of relapses and EDSS-scale increase. The imaging measures will be analyzed by increase cranial lesions on MRI. This date will be correlated with quantitative assessment of HERV-W and viruses of the Herpesviridae family.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study group will be composed by patients diagnosed with multiple sclerosis and with other neurological diseases ( Lateral AmniotroficSclerosis, Headache, Parkinson's, Dementia and Epilepsy). And the control group will be composed by blood donors who are considered healthy control.
Criteria

Inclusion Criteria:

  • patients diagnosed with multiple sclerosis;
  • patients diagnosed with other neurological diseases (Lateral Amniotrofic Sclerosis , Headache, Parkinson's, Dementia and Epilepsy);
  • healthy control: blood donors;

Exclusion Criteria:

  • patients diagnosed with other non-neurological diseases;

Publications of Results:

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Responsible Party: Guilherme Sciascia do Olival, expert - medical residence, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier: NCT02489877     History of Changes
Other Study ID Numbers: Fcmscsp-HERV
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015

Keywords provided by Guilherme Sciascia do Olival, Faculdade de Ciências Médicas da Santa Casa de São Paulo:
multiple sclerosis
HERV-W virus
Herpesviridae family

Additional relevant MeSH terms:
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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