Plexin D1 as a Potential Biomarker inPM/DM

NCT ID: NCT05637931

Last Updated: 2022-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-25

Study Completion Date

2024-01-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polymyositis Dermatomyositis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

adult polymyositis and dermatomyositis

plexinD1

Intervention Type DIAGNOSTIC_TEST

evaluation of the serum level of plexinD1

juvenile dermatomyositis

plexinD1

Intervention Type DIAGNOSTIC_TEST

evaluation of the serum level of plexinD1

healthy controls

plexinD1

Intervention Type DIAGNOSTIC_TEST

evaluation of the serum level of plexinD1

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

plexinD1

evaluation of the serum level of plexinD1

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Reham Khalifa Ali Khalifa

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eman Ahmed Hamed Omran, professor

Role: STUDY_DIRECTOR

Assiut University

Manal Hassanien, professor

Role: STUDY_DIRECTOR

Assiut University

Ahmed Abdel Khalek Hafez, lecturer

Role: STUDY_DIRECTOR

Assiut University

Helal F. Hetta, professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Reham Khalifa Ali Khalifa, doctor

Role: CONTACT

+201023152733

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND
PMID: 16901073 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34158841 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18586175 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21376512 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29122679 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29855735 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26554931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34297034 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

plexinD1 in PM/DM

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Platelet Gel in Systemic Sclerosis
NCT00463125 UNKNOWN PHASE2/PHASE3
Diabetes and Psoriasis
NCT02366273 COMPLETED