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STAT4 in Multiple Sclerosis by PCR and Flow Cytometry

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ClinicalTrials.gov Identifier: NCT03893344
Recruitment Status : Not yet recruiting
First Posted : March 28, 2019
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Mai Mohammed SalahElDin, Assiut University

Brief Summary:
  1. To determine the level of STAT4 expression in different cases of multiple sclerosis and its relation to disease severity .
  2. compare the sensitivity and specificity of STAT4 levels using both PCR and flow cytometry.

Condition or disease Intervention/treatment
Multiple Sclerosis Diagnostic Test: detection of STAT4 gene

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 104 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Detection of STAT4 in Multiple Sclerotic Patients by Polymerase Chain Reaction and Flow Cytometry
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cases
patients with Multiple Sclerosis in different stages diagnosed clinically according to revised McDonald's criteria 2010
Diagnostic Test: detection of STAT4 gene
Individuals within both groups will be subjected to STAT4 gene polymorphism typing using both PCR and flow cytometry from a peripheral blood sample

Control
Healthy peaple
Diagnostic Test: detection of STAT4 gene
Individuals within both groups will be subjected to STAT4 gene polymorphism typing using both PCR and flow cytometry from a peripheral blood sample




Primary Outcome Measures :
  1. To determine the level of STAT4 expression in different cases of multiple sclerosis [ Time Frame: baseline ]
    measuring the level of STAT4 gene in both the control group and different cases of multiple sclerotic and its relation to disease pathogenesis and severity


Secondary Outcome Measures :
  1. compare the sensitivity and specificity of STAT4 levels using both PCR and flow cytometry. [ Time Frame: baseline ]
    compare the sensitivity and specificity of STAT4 levels using both PCR and flow cytometry in peripheral blood sample which is easy and safe diagnostic method.



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
MS patients, fulfilling the inclusion criteria for the research, will be selected from Assiut University Hospital.
Criteria

Inclusion Criteria:

  • The diagnosis of MS patients will be established clinically from the history according to revised McDonald's criteria 2010.

Exclusion Criteria:

  • Patients proved not to have MS either at first interview or at any time during follow up or with other autoimmune diseases will be ruled out of the study.
  • Healthy group with past or present medical history of autoimmune disease or other neurologic condition.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893344


Contacts
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Contact: Mai M SalahElDin, Ass.Lecturer 01007508723 mai_galaxyy@yahoo.com
Contact: Randa A El Zohni, Lecturer 01003390690 randaelzohne@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Ahmed K Mostafa, Professor Assiut University

Additional Information:
Publications:
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Responsible Party: Mai Mohammed SalahElDin, Assistant Lecturer at Assiut University, Assiut University
ClinicalTrials.gov Identifier: NCT03893344     History of Changes
Other Study ID Numbers: STAT4 gene in MS.
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases