Clinical Database and Biobank of Patients With Inflammatory Myopathies: the MASC Project (Myositis, DNA, Serum, Cells) (MASC)

NCT04637672 | Completed

• 1 other identifier: CIC-1421-20-04
• Study Type: observational
• Target: 1,273
• Locations: 1 country
• Sites: 1

Brief Summary

Myositis are rare diseases for which the development of a cohort associated with a bank of biological samples (biobank) will allow for the conduct of researches to better delineate the underlying pathophysiology and find cures. This prospective cohort of patients with myositis will allow for identification of factors favouring the occurrence of myositis, whether they are constitutional (genetic) or acquired (environmental or drug). Different subgroups of myositis used for prognostication will be identified based on clinico-demographical variables, the nature of the organs involved beyond peripheral muscles (cardiac, diaphragm) and biomarkers abnormalities.

Conditions

Inflammatory Myositis; Idiopathic Inflammatory Myositis; Drug-induced Inflammatory Myositis

Outcome Measures

Primary Outcomes (1)

• Characterisation of the different myositis subgroups based on clinical, radiological, electrophysiological and histo-biological evaluations

  Characterisation of the different myositis subgroups based on clinical, radiological, electrophysiological and histo-biological evaluations, including but not limited to: sexe, age, profession, a history of infection, cancer or other autoimmune and inflammatory diseases, diagnosis criteria, creatine phosphokinase, autoantibodies, immune systeme evaluation based on peripheral blood mononuclear cells, DNA sequencing muscular biopsies

  baseline: first 30 days after inclusion

Secondary Outcomes (14)

• Characterisation of the natural history of myositis subgroups :responses to treatments, prognosis factors, evolution

  up to twenty years after inclusion

• Characterisation of an immune system signature, using peripheral blood mononuclear cells and muscular biopsies, DNA and RNA sequencing, and autoantibodies

  baseline: first 30 days after inclusion

• Risk factors for All-cause mortality depending on patient's and disease characteristics

  up to twenty years after inclusion

• Change of the quality of life, using quality of life questionnaires, depending of patients and disease characteristics

  up to twenty years after inclusion

• Change of activity impairment using an evaluation of daily life activity by both patient and physician using a Visual Analogue Scale depending of patients and disease characteristics

  up to twenty years after inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who had a confirmed or suspected myositis

You may qualify if:

• All patients who had a confirmed (muscular biopsy, electromyogram, magnetic resonance imaging) or suspected clinically myositis. Myositis criteria are as follow:
• Dermatomyositis or polymyositis according to Bohan and Peter criteria (1975)
• Necrotizing autoimmune myopathy according to Hoogendijk et al. criteria (2004)
• Drug-induced myositis
• Signature of the informed consent form for the study and for the biobank
• Age over 18 years old

You may not qualify if:

• None

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead

Study Sites (1)

AP-HP, Pitié-Salpêtrière Hospital, Department of Internal Medicine and clinical immunology

Paris, 75013, France

Location

Related Publications (2)

• Teboul A, Allenbach Y, Tubach F, Belin L, Cassius C, Demortier J, Dossier A, Faucon C, Kasser C, Mekinian A, Monseau G, Fouchard M, Chambrelan E, Viguier M, Kluger N, Mahevas T, Bergeret B, Bachmeyer C, Lenormand C, Hotz C, Diaz E, Cordel N, Benveniste O, Bessis D, Bouaziz JD, Chasset F. Prognostic factors for patients with cancer-associated dermatomyositis: a retrospective, multicentre cohort study of 73 patients. Rheumatology (Oxford). 2025 May 1;64(5):2970-2978. doi: 10.1093/rheumatology/keae629.

  PMID: 39589730 DERIVED

• Demortier J, Vautier M, Chosidow O, Gallay L, Bessis D, Berezne A, Cordel N, Schmidt J, Smail A, Duffau P, Jachiet M, Begon E, Gottlieb J, Chasset F, Graveleau J, Marque M, Cesbron E, Forestier A, Josse S, Kluger N, Beauchene C, Le Corre Y, Pagis V, Rigolet A, Guillaume-Jugnot P, Authier FJ, Guilain N, Streichenberger N, Leonard-Louis S, Boussouar S, Landon-Cardinal O, Benveniste O, Allenbach Y. Anti-SAE autoantibody in dermatomyositis: original comparative study and review of the literature. Rheumatology (Oxford). 2023 Dec 1;62(12):3932-3939. doi: 10.1093/rheumatology/kead154.

  PMID: 37010495 DERIVED

MeSH Terms

Conditions

Myositis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Olivier Benveniste, PU PH

  Groupe Hospitalier Pitie-Salpetriere

  STUDY DIRECTOR

• Yves Allenbach

  Groupe Hospitalier Pitie-Salpetriere

  STUDY DIRECTOR

• Joe Elie SALEM

  Groupe Hospitalier Pitie-Salpetriere

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 100 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: November 20, 2020
• Study Start: December 19, 2013
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: May 22, 2024

Record last verified: 2023-09

Locations

FR (1)