Status:

RECRUITING

New Approaches for Evaluating the Interchangeability of Reference Materials and Quality Controls (COMET-MPL)

Lead Sponsor:

University Hospital, Montpellier

Conditions:

Hospitalization

All Conditions

Eligibility:

All Genders

18+ years

Brief Summary

Medical biology tests are essential to clinical decision-making. The European Regulation on in vitro diagnostic medical devices (EU/2017/746) requires metrological traceability of the values assigned ...

Detailed Description

The global in vitro diagnostics (IVD) market was valued at €91.1 billion in 2023 and is projected to reach €147.3 billion by 2030, reflecting its growing strategic importance in healthcare. Medical bi...

Eligibility Criteria

Inclusion

  • Panel 1: adults ≥ 18 years of age.
  • Panel 2: adults ≥ 18 years of age undergoing immunosuppressive treatment (cyclosporine, everolimus, tacrolimus, sirolimus).

Exclusion

  • Protected patients (minors who are not emancipated, individuals who are unable to express their consent, etc.)
  • Individuals who are not affiliated with a social security system
  • Individuals under judicial protection
  • Refusal to give consent to participate in the research

Key Trial Info

Start Date :

September 22 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 22 2026

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT07173114

Start Date

September 22 2025

End Date

September 22 2026

Last Update

September 30 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

University Hospital Montpellier

Montpellier, France

2

University Hospital, Montpellier

Montpellier, France