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

NCT07173114 | Recruiting

• 1 other identifier: RECHMPL24_0369
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Hospitalization; All Conditions

Keywords

In Vitro Diagnostics (IVD); Commutability; Calibration; Interchangeability; Analytical Validity

Outcome Measures

Primary Outcomes (1)

• Assessment of Commutability

  The primary endpoint is the analytical data associated with the biomarker in question obtained from the blood sample: commutability will be assessed by comparing the behavior of certified reference materials (CRMs) and external quality controls (EQA) with the results from fresh serum.

  1 day

Secondary Outcomes (17)

• Serum Testosterone Concentration

  1 day

• Serum Calcium Concentration

  1 day

• Serum Glucose Concentration

  1 day

• Total Cholesterol Concentration

  1 day

• High-Density Lipoprotein Cholesterol (HDL-C) Concentration

  1 day

Study Arms (2)

Panel 1

Patients aged 18 years or older

Panel 2

Patients aged 18 years or older receiving immunosuppressive therapy (cyclosporine and/or everolimus and/or tacrolimus and/or sirolimus)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population consists of patients hospitalized in the departments of the investigative teams at Montpellier University Hospital, regardless of their pathologies.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

University Hospital Montpellier

Montpellier, France

RECRUITING

University Hospital, Montpellier

Montpellier, France

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Recruiting a panel of fresh clinical samples with values close to those of standards or quality controls requires the collection of three 7 mL tubes of blood during a scheduled check-up as part of routine care. After centrifugation, the serum will be aliquoted and the samples sent to the various medical laboratories performing the assays for which commutability will be evaluated.

Study Officials

• Jean-Paul CRISTOL, PUPH

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Paul CRISTOL, PUPH

CONTACT

+33 0467338314; jp-cristol@chu-montpellier.fr

Vincent DELATOUR, Dr

CONTACT

Vincent.delatour@lne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 15, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): September 22, 2026
• Study Completion (Estimated): September 22, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

FR (2)