Improving interchangeability of reference materials and quality controls for laboratory tests
Official title: New Approaches for Evaluating the Interchangeability of Reference Materials and Quality Controls (COMET-MPL)
Run by University Hospital, Montpellier · NCT07173114 · Data updated 2026-11-12
This project tests whether specially made reference materials and quality controls behave like real patient samples on automated lab machines for adults, including people taking certain immunosuppressant medicines.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 2 sites (Montpellier and 1 other locations) |
| Status | Recruiting |
| Started | September 22, 2025 |
| Main results expected | September 22, 2026 |
| Study ends | September 22, 2026 |
| Registry record updated | September 30, 2025 |
| Trial ID | NCT07173114 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 and over, including a subgroup of adults taking immunosuppressive medications such as cyclosporine, tacrolimus, everolimus, or sirolimus, are the intended participants.
✕Probably not a fit
People under 18, legally protected individuals or those unable to give informed consent, and individuals not affiliated with a social security system are not eligible and would not directly benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
COMET-MPL examines the commutability and interchangeability of certified reference materials (CRMs) and external quality controls (EQA) when prepared as multiparametric materials for use on high-throughput automated analyzers. The project compares the performance of these materials to native patient samples across routine clinical laboratory platforms, including a general adult panel and a panel of adults receiving immunosuppressive drugs (cyclosporine, tacrolimus, everolimus, sirolimus). Methods include producing single-parameter commutable preparations, running them on multiple automated systems, and analyzing matrix effects and traceability to reference measurement procedures. The goal is to optimize manufacturing processes so controls and calibrators can reliably support standardized, traceable lab results that meet EU regulatory requirements.
Why it matters
Potential benefit: If successful, this work could make lab test results more accurate and comparable across machines and laboratories and help manufacturers meet EU traceability rules.
How similar studies have gone: Previous research has shown commutability can be achieved for some analytes and platforms, but many routine parameters remain without suitable reference materials, so this project builds on partial prior successes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Panel 1: adults ≥ 18 years of age. * Panel 2: adults ≥ 18 years of age undergoing immunosuppressive treatment (cyclosporine, everolimus, tacrolimus, sirolimus). Exclusion Criteria: * 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
Where it's running
-
University Hospital Montpellier
Montpellier, France Recruiting -
University Hospital, Montpellier
Montpellier, France Not yet recruiting
Study contacts
- Principal investigator: Jean-Paul CRISTOL, PUPH — University Hospital, Montpellier
- Study coordinator: Jean-Paul CRISTOL, PUPH
- Email: jp-cristol@chu-montpellier.fr
- Phone: +33 0467338314
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.