Plexin D1 as a Potential Biomarker inPM/DM

November 25, 2022 updated by: Reham Khalifa Ali Khalifa, Assiut University

Evaluation of Circulating PlexinD1 as a Potential Biomarker of Polymyositis and Dermatomyositis.

evaluation of level of serum circulating plexin D1 on extacellular vesicles in adult PM/DM patients and juvenile dermatomysitis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Polymyositis (PM) and dermatomyositis (DM) are autoimmune inflammatory diseases that primarily target muscle.

autoimmune Dermatomyositis (DM) is a rare inflammatory disease that mainly affects skin, muscle, and lung.

Inflammatory myopathies (IMs) often have distinct histopathologic features suggesting humorally mediated involvement of the microcirculation in dermatomyositis (DM), including early capillary deposition of the complement C5b-9 membranolytic attack complex (MAC) and secondary ischaemic changes; and CD8 T-cell-mediated and MHC1-restricted autoimmune attack of myofibers in polymyositis (PM) and inclusion body myositis.

Plexins are a conserved family of large proteins (~200kDa) that are the canonical receptors for semaphorin molecules. Plexins are divided into four classes, A through D.

Recently, plexin and semaphorin molecules have been shown to control cell movement and cell-cell interaction in the immune system .

Extracellular vesicles (EVs) are lipid bilayer membrane vesicles that exist in various bodily fluids. EVs are released by normal, diseased, and transformed cells in vitro and in vivo and are capable of carrying lipids, proteins, mRNAs, non-coding RNAs, and even DNA. They are abundant in serum and plasma and have been a source of considerable interest as potential disease biomarkers. Normally, they maintain physiological functions by transferring biological information to neighboring cells and facilitating intercellular communication, but are also involved in the pathogenesis of numerous autoimmune diseases LC/MS analysis identified 1220 proteins in serum EVs. Of these, plexin D1 was enriched in those from PM/DM patients.

Study Type

Observational

Enrollment (Anticipated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

3 groups under the study adult polymyositis and dermatomyositis,juvenile dermatomyositis. and healthy control .22 subjects in each group.

Description

Inclusion Criteria:

  1. Adult PM/DM patients .
  2. Juvenile dermatomyositis patients.

Exclusion Criteria:

  • 1-Patients with other autoimmune diseases ( rheumatoid arthritis ,systemic lupus erythematosus, polyarteritis nodosa sarcoidosis, scleroderma, spondylarthritis and inflammatory bowel disease) 2-Patients with malignant tumors 3-Patients with active infection 4-Patients with severe heart, lung, and kidney dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
adult polymyositis and dermatomyositis
Diagnostic test: plexinD1
evaluation of the serum level of plexinD1
juvenile dermatomyositis
Diagnostic test: plexinD1
evaluation of the serum level of plexinD1
healthy controls
Diagnostic test: plexinD1
evaluation of the serum level of plexinD1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of circulating PlexinD1 as a potential biomarker of polymyositis and dermatomyositis.
Time Frame: baseline
evaluation of plexinD1in PM/DM patients
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Eman Ahmed Hamed Omran, professor, Assiut University
  • Study Director: Manal Hassanien, professor, Assiut University
  • Study Director: Ahmed Abdel Khalek Hafez, lecturer, Assiut University
  • Study Director: Helal F. Hetta, professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 25, 2022

Primary Completion (Anticipated)

December 25, 2023

Study Completion (Anticipated)

January 25, 2024

Study Registration Dates

First Submitted

November 25, 2022

First Submitted That Met QC Criteria

November 25, 2022

First Posted (Estimate)

December 6, 2022

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

November 25, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • plexinD1 in PM/DM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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