NCT07173114 New Approaches for Evaluating the Interchangeability of Reference Materials and Quality Controls (COMET-MPL)
| NCT ID | NCT07173114 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Hospitalization |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-09-22 |
| Primary Completion | 2026-09-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-09-22 with a primary completion date of 2026-09-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 to calibrators and quality controls, based on reference measurement methods (RMMs) or certified reference materials (CRMs). However, these references are not available for all analyses, limiting manufacturers' ability to comply with regulatory requirements. The dissemination of traceability relies mainly on CRMs. However, to guarantee the validity of the results, these materials must have sufficient commutability, i.e., behavior comparable to that of native biological samples. This property is also required for external quality controls (EQA) used in external quality control programs. Commutability is an essential condition for avoiding matrix effects and ensuring the reliability of results. The COMET-MPL project aims to optimize manufacturing processes for commutable, single-parameter, or multi-parameter CRMs and EQA. Evaluate the commutability of these materials in relation to patient samples. The COMET-MPL project aims to Produce materials suitable for priority analyses: bilirubin, cyclosporine, parathyroid hormone (PTH), human cytomegalovirus, estradiol. Commutability will be verified by comparing the performance of CRMs and EQA with that of clinical samples in several French laboratories equipped with automated systems from different manufacturers.
Eligibility 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
Contact & Investigator
Jean-Paul CRISTOL, PUPH
PRINCIPAL INVESTIGATOR
University Hospital, Montpellier
Frequently Asked Questions
Who can join the NCT07173114 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hospitalization. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07173114 currently recruiting?
Yes, NCT07173114 is actively recruiting participants. Contact the research team at jp-cristol@chu-montpellier.fr for enrollment information.
Where is the NCT07173114 trial being conducted?
This trial is being conducted at Montpellier, France, Montpellier, France.
Who is sponsoring the NCT07173114 clinical trial?
NCT07173114 is sponsored by University Hospital, Montpellier. The principal investigator is Jean-Paul CRISTOL, PUPH at University Hospital, Montpellier. The trial plans to enroll 300 participants.