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Trial record 19 of 598 for:    Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

MYOPROSP - a Prospective Cohort Study in Myositis (MYOPROSP)

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ClinicalTrials.gov Identifier: NCT02468895
Recruitment Status : Recruiting
First Posted : June 11, 2015
Last Update Posted : February 1, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Adult patients with suspected or confirmed idiopathic inflammatory myopathy (IIM) will be recruited. Patients will be approached, consented, have baseline demographics, diagnostics and disease activity measures recorded, and blood taken. The collection of data and biological material will mirror usual clinical practice as far as possible. Subjects will ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures recorded and questionnaires completed.

In addition, blood, muscle biopsies and imaging undertaken as part of usual care will also be collected for research purposes to measure a number of biomarkers for the assessment of diagnostic accuracy and clinical utility evaluation. As per usual practice, a muscle biopsy will be performed at baseline, and a further biopsy offered at 6 months to assess treatment response. A magnetic resonance (MR) muscle protocol will also be performed as per usual clinical practice, and a gadolinium-enhanced MR heart scan offered. Both these scans will be repeated at 6 months. An existing electronic database entry system will be used for data entry and capture on an anonymised basis.

The study will thus be based around diagnostic evaluations and outcome measures to improve quality of care in IIM.


Condition or disease
Myositis Idiopathic Inflammatory Myopathy

  Show Detailed Description

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: MYOPROSP: A Prospective Cohort Study to Identify a Stratified Approach in the Diagnosis, Treatment and Delivery of Care in Adult Idiopathic Inflammatory Myopathy
Actual Study Start Date : October 4, 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021


Groups and Cohorts

Group/Cohort
Idiopathic Inflammatory Myopathy
PM, DM, sIBM, necrotizing myopathy, anti-synthetase syndrome, suspected myopathy


Outcome Measures

Primary Outcome Measures :
  1. Number of participants with a significant change levels of diagnostic biomarkers. [ Time Frame: 5 years ]
    This will depend on the specific biomarker/cytokine being measured


Secondary Outcome Measures :
  1. Number of participants with a 20% improvement in myositis specific disease activity measures from baseline [ Time Frame: 5 years ]
    As per the published International Myositis Assessment & Clinical Studies Group (IMACS) outcome measures of definition of improvement (http://www.niehs.nih.gov/research/resources/imacs/definitions/index.cfm)

  2. Differences in frequency of genetic variants associated with IIM and subtypes compared to population matched controls [ Time Frame: 5 years ]
    Specific identified genetic variants will be identified as part of large scale genetic studies


Biospecimen Retention:   Samples With DNA
DNA RNA Peripheral blood mononuclear cells Serum Plasma Urine Muscle biopsies Other diagnostic tissue

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Idiopathic Inflammatory Myopathy, UK based patients
Criteria

Gender Both female and males

Age limits Patients >/= 18 years

Accept healthy volunteers No

Eligibility criteria

Inclusion Criteria:

  • Polymyositis
  • Dermatomyositis (including amyopathic)
  • Inclusion body myositis
  • Anti-synthetase syndrome
  • Myositis overlapping with another connective tissue disorder
  • Cancer-associated myositis
  • Immune-mediated necrotising myopathy including statin-induced myositis
  • Juvenile myositis persisting into adulthood
  • Fasciitis including eosinophilic myofasciitis
  • Vasculitis affecting muscle
  • Granulomatous myositis
  • Focal myositis
  • Orbital myositis
  • Suspected myositis under investigation
  • CTD features in association with a myositis specific / associated antibody

Exclusion Criteria:

  • Patients with disease duration >2 years
  • Patients < 18 years
  • Confirmed non-inflammatory myopathies
  • Myositis secondary to alcohol or drug abuse
  • Patients unwilling or unable to give consent
  • Patients with poor or no venous access
  • Patients where MR imaging is contraindicated (for MR substudy)

Study population description Patients referred to tertiary level UK myositis clinics

Sampling methods N/A, this is a prospective study of consecutive eligible patients

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468895


Contacts
Contact: Hector Chinoy, PhD FRCP +441612755993 hector.chinoy@manchester.ac.uk

Locations
United Kingdom
The University of Manchester Recruiting
Manchester, Please Select, United Kingdom, M13 9PT
Contact: Paul New    +442755993    paul.new@liverpool.ac.uk   
Sponsors and Collaborators
University of Manchester
University of Bath
University College, London
Royal Victoria Infirmary
King's College Hospital NHS Trust
North Bristol NHS Trust
University of Liverpool
St. George's Hospital, London
Salford Royal NHS Foundation Trust
Investigators
Principal Investigator: Hector Chinoy, PhD FRCP The University of Manchester
More Information

Responsible Party: Hector Chinoy, Senior Lecturer, University of Manchester
ClinicalTrials.gov Identifier: NCT02468895     History of Changes
Other Study ID Numbers: UoMMYO
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Core/extended dataset, SOP definitions, data access/sharing policies, data available for sharing and metadata to describe these, will be made available though the planned UKMYONET study website, meetings and presentations. Links to the results and the UKMYONET website will be available via the Euromyositis registry front page and links from local CoI websites. All data generated during this project will be made available to the scientific community through full publication in a timely fashion using open access in highest possible impact scientific journals, presentation at scientific conferences and via SC application for data access. Genotype data will be deposited and made available through a publically available repository, such as the European Bioinformatics Institute, for secure data storage.

Keywords provided by Hector Chinoy, University of Manchester:
Myositis
Idiopathic inflammatory myopathy
Antibodies
Genetics
Biomarkers

Additional relevant MeSH terms:
Muscular Diseases
Myositis
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases