Plexin D1 as a Potential Biomarker inPM/DM

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05637931
Collaborator
(none)
66
13

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: plexinD1

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 Design

Study Type:
Observational
Anticipated Enrollment :
66 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Evaluation of Circulating PlexinD1 as a Potential Biomarker of Polymyositis and Dermatomyositis.
Anticipated Study Start Date :
Dec 25, 2022
Anticipated Primary Completion Date :
Dec 25, 2023
Anticipated Study Completion Date :
Jan 25, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of circulating PlexinD1 as a potential biomarker of polymyositis and dermatomyositis. [baseline]

    evaluation of plexinD1in PM/DM patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Reham Khalifa Ali Khalifa, doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05637931
Other Study ID Numbers:
  • plexinD1 in PM/DM
First Posted:
Dec 6, 2022
Last Update Posted:
Dec 6, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 6, 2022