Plexin D1 as a Potential Biomarker inPM/DM

Dermatomyositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05637931
• Other study ID #: plexinD1 in PM/DM
• Status: Not yet recruiting
• Start date: December 25, 2022
• Est. completion date: January 25, 2024

Study information

• Verified date: November 2022
• Source: Assiut University
• Contact: Reham Khalifa Ali Khalifa, doctor
• Phone: +201023152733
• Email: Rehamkhalefa96[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: January 25, 2024
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatomyositis
• Polymyositis

Intervention

Diagnostic Test:
• plexinD1
evaluation of the serum level of plexinD1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

Devhare PB, Ray RB. Extracellular vesicles: Novel mediator for cell to cell communications in liver pathogenesis. Mol Aspects Med. 2018 Apr;60:115-122. doi: 10.1016/j.mam.2017.11.001. Epub 2017 Nov 11. — View 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. — View Citation

Gherardi RK. Pathogenic aspects of dermatomyositis, polymyositis and overlap myositis. Presse Med. 2011 Apr;40(4 Pt 2):e209-18. doi: 10.1016/j.lpm.2010.12.013. Epub 2011 Mar 3. — View Citation

Lane RE, Korbie D, Hill MM, Trau M. Extracellular vesicles as circulating cancer biomarkers: opportunities and challenges. Clin Transl Med. 2018 May 31;7(1):14. doi: 10.1186/s40169-018-0192-7. — View Citation

Li Y, Bax C, Patel J, Vazquez T, Ravishankar A, Bashir MM, Grinnell M, Diaz D, Werth VP. Plasma-derived DNA containing-extracellular vesicles induce STING-mediated proinflammatory responses in dermatomyositis. Theranostics. 2021 May 21;11(15):7144-7158. doi: 10.7150/thno.59152. eCollection 2021. — View Citation

Turpin D, Truchetet ME, Faustin B, Augusto JF, Contin-Bordes C, Brisson A, Blanco P, Duffau P. Role of extracellular vesicles in autoimmune diseases. Autoimmun Rev. 2016 Feb;15(2):174-83. doi: 10.1016/j.autrev.2015.11.004. Epub 2015 Nov 7. — View 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. — View Citation

Ytterberg SR. Treatment of refractory polymyositis and dermatomyositis. Curr Rheumatol Rep. 2006 Jun;8(3):167-73. doi: 10.1007/s11926-996-0021-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of circulating PlexinD1 as a potential biomarker of polymyositis and dermatomyositis.	evaluation of plexinD1in PM/DM patients	baseline