NCT04300543

Brief Summary

A study To analyse the expression of circulating miR-150 and miR-155 in serum of MS patients, Evaluate the serum levels of oligoclonal bands, neurofilaments and chitinase-3-like-1 in serum of MS patients, and Investigate the correlation between the measured biomarkers and each other and their correlation with different MS phenotypes , disability status and the patients demographic data.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Status
unknown

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 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 5, 2020

Last Update Submit

March 5, 2020

Conditions

Multiple Sclerosis

Keywords

MicroRNA in MS

Outcome Measures

Primary Outcomes (2)

  • analyse the expression of circulating miR-150 and miR-155 in serum of MS patients

    to measure the levels of miR-150 and miR-155 in different MS phenotypes

    baseline

  • Evaluate the serum levels of oligoclonal bands, neurofilaments and chitinase-3-like-1 in serum of MS patients

    measure the levels of OCB, NF-L and NF-H , and CHI3L1 in different MS phenotypes

    baseline

Secondary Outcomes (1)

  • Investigate the correlation between the measured biomarkers and each other and their correlation with different MS phenotypes , disability status and the patients demographic data

    baseline

Study Arms (3)

Group 1 MS patients

patients with multiple sclerosis

Group 2 patients with other neurological disorders

patients with inflammatory or non inflammatory neurological diseases other than multiple sclerosis

Group 3 healthy control

No neurological or immunological disease

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

140 participants will be enrolled into a study to examine the microRNA and other mentioned biomarkers in their serum, Study population will consist of a total of :80 MS patients recruited among the attendants of out and in patients of neuropsychatric department, 40 with other neurological diseases , 20 healthy control

You may qualify if:

  • Patients diagnosed as MS (clinically and by imaging) according to revised 2017 McDonald Criteria .
  • Each patient will be subjected to complete medical history uptake including : Age, Sex, age at onset of the disease, phenotype of the disease and its duration, frequency of relapses and remissions , EDSS(The Expanded Disability Status Scale ) is a method of quantifying disability in multiple sclerosis) and MRI findings.

You may not qualify if:

  • Patients with non neurological autoimmune diseases, malignancy, cardiac and renal diseases that can affect level of miRNAs .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Bergman P, Piket E, Khademi M, James T, Brundin L, Olsson T, Piehl F, Jagodic M. Circulating miR-150 in CSF is a novel candidate biomarker for multiple sclerosis. Neurol Neuroimmunol Neuroinflamm. 2016 Apr 20;3(3):e219. doi: 10.1212/NXI.0000000000000219. eCollection 2016 Jun.

    PMID: 27144214BACKGROUND

  • Jagot F, Davoust N. Is It worth Considering Circulating microRNAs in Multiple Sclerosis? Front Immunol. 2016 Apr 5;7:129. doi: 10.3389/fimmu.2016.00129. eCollection 2016.

    PMID: 27092141BACKGROUND

  • Chen C, Zhou Y, Wang J, Yan Y, Peng L, Qiu W. Dysregulated MicroRNA Involvement in Multiple Sclerosis by Induction of T Helper 17 Cell Differentiation. Front Immunol. 2018 Jun 4;9:1256. doi: 10.3389/fimmu.2018.01256. eCollection 2018.

    PMID: 29915595BACKGROUND

  • Harris VK, Tuddenham JF, Sadiq SA. Biomarkers of multiple sclerosis: current findings. Degener Neurol Neuromuscul Dis. 2017 Jan 12;7:19-29. doi: 10.2147/DNND.S98936. eCollection 2017.

    PMID: 30050375BACKGROUND

  • Hu Z, Cui Y, Qiao X, He X, Li F, Luo C, Wang S, Li C, Dai R. Silencing miR-150 Ameliorates Experimental Autoimmune Encephalomyelitis. Front Neurosci. 2018 Jul 10;12:465. doi: 10.3389/fnins.2018.00465. eCollection 2018.

    PMID: 30050402BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

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

  • Sahar Eldeek, Ph.D.

    Assiut University

    STUDY DIRECTOR

  • Sally Mohamed

    Assiut University

    STUDY DIRECTOR

  • Lamia Ahmed

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lamia Ahmed, MD

CONTACT

01019956057lamiaahmed43@yahoo.com

Sally Mohamed, Ph.D.

CONTACT

01004419975sallybakkar39@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Administrator

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 9, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2021

Study Completion

October 1, 2021

Last Updated

March 9, 2020

Record last verified: 2020-03