deltatrials
Active Not Recruiting OBSERVATIONAL NCT01171573

Investigating Genes in Patients With Polymyositis and Dermatomyositis (UKMYONET)

Identification of Disease Susceptibility Genes Associated With Development and Clinical Characteristics of Primary Inflammatory Muscle Diseases, PM, DM and IBM.

Sponsor: Northern Care Alliance NHS Foundation Trust

Conditions Myositis
Interventions Venepuncture
Updated 16 times since 2017 Last updated: Apr 4, 2023 Started: Jan 31, 2001 Primary completion: Dec 31, 2030 Completion: Dec 31, 2030
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Myositis, this trial is ongoing. The trial is conducted by Northern Care Alliance NHS Foundation Trust and has accumulated 16 data snapshots since 2001. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

In order to understand the genetic aspects / causes of myositis, and ultimately develop more effective treatment therapies, it will be necessary to collect blood samples and clinical details from around 1000 patients with myositis. As the condition is very rare, it will not be possible to get the required number of patients from one centre alone, and therefore, a collaborative, multicentred approach will be needed. Consultant rheumatologists and neurologists throughout the UK, who have patients with PM, DM or IBM, will be approached, and asked if they would like to officially enter into the myositis genomic multicentred study. Once ethical and R\&D approval has been granted, consultants will be named as the 'Principal Investigators' at each of these 'research sites' and could then start to recruit suitable patients into the study. Patients from each research site, with definite PM, DM or IBM, will be asked by their own consultants (Principal Investigator) to give 20 mls of blood via venepuncture for genetic and antibody analysis. The PI will also complete a clinical/laboratory proforma, for each patient, regarding their disease characteristics, to allow subsequent confirmation that patients' disease is indeed definite, and this proforma and the blood sample will be sent...

In order to understand the genetic aspects / causes of myositis, and ultimately develop more effective treatment therapies, it will be necessary to collect blood samples and clinical details from around 1000 patients with myositis. As the condition is very rare, it will not be possible to get the required number of patients from one centre alone, and therefore, a collaborative, multicentred approach will be needed. Consultant rheumatologists and neurologists throughout the UK, who have patients with PM, DM or IBM, will be approached, and asked if they would like to officially enter into the myositis genomic multicentred study. Once ethical and R\&D approval has been granted, consultants will be named as the 'Principal Investigators' at each of these 'research sites' and could then start to recruit suitable patients into the study.

Patients from each research site, with definite PM, DM or IBM, will be asked by their own consultants (Principal Investigator) to give 20 mls of blood via venepuncture for genetic and antibody analysis. The PI will also complete a clinical/laboratory proforma, for each patient, regarding their disease characteristics, to allow subsequent confirmation that patients' disease is indeed definite, and this proforma and the blood sample will be sent to CIGMR. All of the genetic analyses, will take place at CIGMR, but storage of clinical details and certain patient identifiers will be stored at SRFT on a password protected NHS tust computer.

This study will be co-ordinated by Dr RG Cooper through the Rheumatic Diseases Centre, Salford Royal NHS Foundation Trust (SRFT), and Professor Bill Ollier from the Centre for Integrated Genomic Medical Research unit (CIGMR), Stopford Building, Manchester University.

Status Flow

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshot~Aug 2017 – ~Apr 2018 · 8 months · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshot~Jan 2019 – ~Nov 2020 · 22 months · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshot~Oct 2021 – ~Dec 2021 · 2 months · monthly snapshot~Dec 2021 – ~Mar 2022 · 3 months · monthly snapshot~Mar 2022 – ~May 2023 · 14 months · monthly snapshot~May 2023 – ~Jul 2024 · 14 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 19 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

16 versions recorded
  1. Jan 2026 — Present [monthly]

    Active Not Recruiting

  2. Sep 2024 — Present [monthly]

    Active Not Recruiting

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting

  4. May 2023 — Jul 2024 [monthly]

    Active Not Recruiting

    Status: RecruitingActive Not Recruiting

  5. Mar 2022 — May 2023 [monthly]

    Recruiting

Show 11 earlier versions
  1. Dec 2021 — Mar 2022 [monthly]

    Recruiting

  2. Oct 2021 — Dec 2021 [monthly]

    Recruiting

    Status: Unknown StatusRecruiting

  3. Jan 2021 — Oct 2021 [monthly]

    Unknown Status

  4. Dec 2020 — Jan 2021 [monthly]

    Unknown Status

    Status: RecruitingUnknown Status

  5. Nov 2020 — Dec 2020 [monthly]

    Recruiting

  6. Jan 2019 — Nov 2020 [monthly]

    Recruiting

  7. Jun 2018 — Jan 2019 [monthly]

    Recruiting

  8. May 2018 — Jun 2018 [monthly]

    Recruiting

  9. Apr 2018 — May 2018 [monthly]

    Recruiting

    Phase: NANone

  10. Aug 2017 — Apr 2018 [monthly]

    Recruiting NA

  11. Jan 2017 — Aug 2017 [monthly]

    Recruiting NA

    First recorded

Jan 2001

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Northern Care Alliance NHS Foundation Trust
Data source: Northern Care Alliance NHS Foundation Trust

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations