NCT05637931

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

December 25, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
Last Updated

December 6, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

November 25, 2022

Last Update Submit

November 25, 2022

Conditions

PolymyositisDermatomyositis

Outcome Measures

Primary Outcomes (1)

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

    evaluation of plexinD1in PM/DM patients

    baseline

Study Arms (3)

adult polymyositis and dermatomyositis

Diagnostic Test: plexinD1

juvenile dermatomyositis

Diagnostic Test: plexinD1

healthy controls

Diagnostic Test: plexinD1

Interventions

plexinD1DIAGNOSTIC_TEST

evaluation of the serum level of plexinD1

adult polymyositis and dermatomyositishealthy controlsjuvenile dermatomyositis

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

3 groups under the study adult polymyositis and dermatomyositis,juvenile dermatomyositis. and healthy control .22 subjects in each group.

You may qualify if:

  • Adult PM/DM patients .
  • Juvenile dermatomyositis patients.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

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

    PMID: 16901073BACKGROUND

  • 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.

    PMID: 34158841BACKGROUND

  • 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.

    PMID: 18586175BACKGROUND

  • 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.

    PMID: 21376512BACKGROUND

  • 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.

    PMID: 29122679BACKGROUND

  • 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.

    PMID: 29855735BACKGROUND

  • 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.

    PMID: 26554931BACKGROUND

  • 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.

    PMID: 34297034BACKGROUND

MeSH Terms

Conditions

PolymyositisDermatomyositis

Condition Hierarchy (Ancestors)

MyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Eman Ahmed Hamed Omran, professor

    Assiut University

    STUDY DIRECTOR

  • Manal Hassanien, professor

    Assiut University

    STUDY DIRECTOR

  • Ahmed Abdel Khalek Hafez, lecturer

    Assiut University

    STUDY DIRECTOR

  • Helal F. Hetta, professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Reham Khalifa Ali Khalifa, doctor

CONTACT

+201023152733Rehamkhalefa96@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

November 25, 2022

First Posted

December 6, 2022

Study Start

December 25, 2022

Primary Completion

December 25, 2023

Study Completion

January 25, 2024

Last Updated

December 6, 2022

Record last verified: 2022-11