NCT03893344

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

September 20, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

8 months

First QC Date

March 26, 2019

Last Update Submit

June 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • To determine the level of STAT4 expression in different cases of multiple sclerosis

    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

    baseline

Secondary Outcomes (1)

  • compare the sensitivity and specificity of STAT4 levels using both PCR and flow cytometry.

    baseline

Study Arms (2)

Cases

patients with Multiple Sclerosis in different stages diagnosed clinically according to revised McDonald's criteria 2010

Diagnostic Test: detection of STAT4 gene

Control

Healthy peaple

Diagnostic Test: detection of STAT4 gene

Interventions

Individuals within both groups will be subjected to STAT4 gene polymorphism typing using both PCR and flow cytometry from a peripheral blood sample

CasesControl

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71111, Egypt

Location

Related Publications (2)

  • Housley WJ, Fernandez SD, Vera K, Murikinati SR, Grutzendler J, Cuerdon N, Glick L, De Jager PL, Mitrovic M, Cotsapas C, Hafler DA. Genetic variants associated with autoimmunity drive NFkappaB signaling and responses to inflammatory stimuli. Sci Transl Med. 2015 Jun 10;7(291):291ra93. doi: 10.1126/scitranslmed.aaa9223.

    PMID: 26062845BACKGROUND
  • Filippi M, Bar-Or A, Piehl F, Preziosa P, Solari A, Vukusic S, Rocca MA. Multiple sclerosis. Nat Rev Dis Primers. 2018 Nov 8;4(1):43. doi: 10.1038/s41572-018-0041-4.

    PMID: 30410033BACKGROUND

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ahmed K Mostafa, Professor

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer at Assiut University

Study Record Dates

First Submitted

March 26, 2019

First Posted

March 28, 2019

Study Start

September 20, 2019

Primary Completion

May 20, 2020

Study Completion

May 22, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations