ClinicalTrials.gg
Status unknownNCT05637931Updated Dec 6, 2022

Plexin D1 as a Potential Biomarker inPM/DM

An observational study in Polymyositis and Dermatomyositis, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2022-12-06.

Primary conditionDermatomyositisRegistry: PolymyositisReclassifiedWhy we changed it
Registry
Polymyositis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Dermatomyositis
Why
  1. The study's listed conditions name Dermatomyositis, a narrower term within Polymyositis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
66
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Polymyositis
  • Dermatomyositis

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03

In context

Dermatomyositis Reclassified

184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.

This study's planned enrollment of 66 is below the median of 179 across 45 observational studies indexed under Dermatomyositis.

Browse Dermatomyositis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Dermatomyositis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Polymyositis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 1-Patients with other 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
66 participants (estimated)
Patient registry
No

Groups and cohorts

  • adult polymyositis and dermatomyositis

    Diagnostic Test: plexinD1

  • juvenile dermatomyositis

    Diagnostic Test: plexinD1

  • healthy controls

    Diagnostic Test: plexinD1

Interventions

  • Diagnostic testplexinD1

    evaluation of the serum level of plexinD1

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What researchers measure

Primary outcomes

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

    evaluation of plexinD1in PM/DM patients

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Ytterberg SR. Treatment of refractory polymyositis and dermatomyositis. Curr Rheumatol Rep. 2006 Jun;8(3):167-73. doi: 10.1007/s11926-996-0021-7. PubMed 16901073 ↗
  • 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. PubMed 34158841 ↗
  • 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. PubMed 18586175 ↗
  • 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. PubMed 21376512 ↗
  • 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. PubMed 29122679 ↗
  • 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. PubMed 29855735 ↗
  • 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. PubMed 26554931 ↗
  • 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. PubMed 34297034 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2022; primary completion for Dec 2023, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2022
First posted
Dec 6, 2022
StartEst.
Dec 25, 2022
Primary completionEst.
Dec 25, 2023
CompletionEst.
Jan 25, 2024
Last update
Dec 6, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05637931
Lead sponsor
Assiut University
Responsible party
Reham Khalifa Ali Khalifa (doctor, Assiut University) — Principal investigator
First posted
Dec 6, 2022
Start date
Dec 25, 2022 (estimated)
Primary completion
Dec 25, 2023 (estimated)
Completion
Jan 25, 2024 (estimated)
Last update
Dec 6, 2022

Study contacts

Reham Khalifa Ali Khalifa, doctor
Contact
Rehamkhalefa96@gmail.com
+201023152733
Eman Ahmed Hamed Omran, professor
study director · Assiut University
Manal Hassanien, professor
study director · Assiut University
Ahmed Abdel Khalek Hafez, lecturer
study director · Assiut University
Helal F. Hetta, professor
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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