PolymyositisNCT05637931
Plexin D1 as a Potential Biomarker inPM/DM
An observational study of Polymyositis and Dermatomyositis, run by Assiut University.
Trial summary
evaluation of level of serum circulating plexin D1 on extacellular vesicles in adult PM/DM patients and juvenile dermatomysitis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Polymyositis, Dermatomyositis
- What is being tested?
- plexinD1
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2022to 25 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 3 groups under the study adult polymyositis and dermatomyositis,juvenile dermatomyositis. and healthy control .22 subjects in each group.
Who may be able to join
- Adult PM/DM patients .
- Juvenile dermatomyositis patients.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Circulating PlexinD1 as a Potential Biomarker of Polymyositis and Dermatomyositis.
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.
- Conditions
- Polymyositis, Dermatomyositis
- Being tested
- plexinD1
- Medical subject headings
- Polymyositis, Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plexinD1Diagnostic test
evaluation of the serum level of plexinD1
| Study group | Role | What they receive |
|---|---|---|
| adult polymyositis and dermatomyositis | Not described Receives: Diagnostic Test: plexinD1 | |
| juvenile dermatomyositis | Not described Receives: Diagnostic Test: plexinD1 | |
| healthy controls | Not described Receives: Diagnostic Test: plexinD1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of circulating PlexinD1 as a potential biomarker of polymyositis and dermatomyositis.
evaluation of plexinD1in PM/DM patients
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start25 Dec 2022 (estimated)
- Primary completion25 Dec 2023 (estimated)
- Study completion25 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PolymyositisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Khalifa Ali Khalifa, Assiut University
- Investigators
- Eman Ahmed Hamed Omran, professor, Study director, Assiut UniversityManal Hassanien, professor, Study director, Assiut UniversityAhmed Abdel Khalek Hafez, lecturer, Study director, Assiut UniversityHelal F. Hetta, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637931
- Sponsor's protocol ID
- plexinD1 in PM/DM
- Status last verified
- Nov 2022
- First submitted
- 25 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 16901073Li 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 34158841Feldman 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 18586175Gherardi 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 21376512Devhare 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 29122679Lane 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 29855735Turpin 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 26554931Uto 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Circulating PlexinD1 as a Potential Biomarker of Polymyositis and Dermatomyositis.
- ClinicalTrials.gov ID
- NCT05637931
- Acronym / sponsor ID
- plexinD1 in PM/DM
- Conditions
- Polymyositis, Dermatomyositis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Dec 2022 (estimated)
- Primary completion
- 25 Dec 2023 (estimated)
- Study completion
- 25 Jan 2024 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| adult polymyositis and dermatomyositis | – | Diagnostic Test: plexinD1 |
| juvenile dermatomyositis | – | Diagnostic Test: plexinD1 |
| healthy controls | – | Diagnostic Test: plexinD1 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 3 groups under the study adult polymyositis and dermatomyositis,juvenile dermatomyositis. and healthy control .22 subjects in each group.
Key inclusion criteria (2 listed)
- Adult PM/DM patients .
- Juvenile dermatomyositis patients.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plexinD1evaluation of the serum level of plexinD1 | Diagnostic test | adult polymyositis and dermatomyositis, healthy controls, juvenile dermatomyositis |
Primary outcome
Evaluation of circulating PlexinD1 as a potential biomarker of polymyositis and dermatomyositis.
Time frame: baseline
evaluation of plexinD1in PM/DM patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Background: PubMed 16901073Ytterberg SR. Treatment of refractory polymyositis and dermatomyositis. Curr Rheumatol Rep. 2006 Jun;8(3):167-73. doi: 10.1007/s11926-996-0021-7.
- Background: PubMed 34158841Li 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.
- Background: PubMed 18586175Feldman 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.
- Background: PubMed 21376512Gherardi 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.
- Background: PubMed 29122679Devhare 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.
- Background: PubMed 29855735Lane 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.
- Background: PubMed 26554931Turpin 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.
- Background: PubMed 34297034Uto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Polymyositis and Dermatomyositis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reham Khalifa Ali Khalifa, doctor (+201023152733, Rehamkhalefa96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of circulating PlexinD1 as a potential biomarker of polymyositis and dermatomyositis. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05637931, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.