Clinical trial NCT05637931: Plexin D1 as a Potential Biomarker inPM/DM
Official title: Evaluation of Circulating PlexinD1 as a Potential Biomarker of Polymyositis and Dermatomyositis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polymyositis
Dermatomyositis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of circulating PlexinD1 as a potential biomarker of polymyositis and dermatomyositis.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Eman Ahmed Hamed Omran, professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Manal Hassanien, professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Ahmed Abdel Khalek Hafez, lecturer
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Helal F. Hetta, professor
role: STUDY_DIRECTOR
References:
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citation: Feldman BM, Rider LG, Reed AM, Pachman LM. Juvenile dermatomyositis and other idiopathic inflammatory myopathies of childhood. Lancet. 2008 Jun 28;371(9631):2201-12. doi: 10.1016/S0140-6736(08)60955-1.
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citation: Uto K, Ueda K, Okano T, Akashi K, Takahashi S, Nakamachi Y, Imanishi T, Awano H, Morinobu A, Kawano S, Saegusa J. Identification of plexin D1 on circulating extracellular vesicles as a potential biomarker of polymyositis and dermatomyositis. Rheumatology (Oxford). 2022 Apr 11;61(4):1669-1679. doi: 10.1093/rheumatology/keab588.