HospitalizationCOMET-MPLNCT07173114
New Approaches for Evaluating the Interchangeability of Reference Materials and Quality Controls (COMET-MPL)
An observational study of Hospitalization and All Conditions, run by University Hospital, Montpellier at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalization, All Conditions
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Sep 2025to 22 Sep 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population consists of patients hospitalized in the departments of the investigative teams at Montpellier University Hospital, regardless of their pathologies.
Who may be able to join
- Panel 1: adults ≥ 18 years of age.
- Panel 2: adults ≥ 18 years of age undergoing immunosuppressive treatment (cyclosporine, everolimus, tacrolimus, sirolimus).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vincent DELATOUR, Dr contact
France2 sites, 2 recruiting
- Recruiting
University Hospital Montpellier
Montpellier
Jean-Paul CRISTOL, PUPH, +33 0467338314, jp-cristol@chu-montpellier.fr
Vincent DELATOUR, Dr, vincent.delatour@lne.fr
- Not yet recruiting
University Hospital, Montpellier
Montpellier
Jean-Paul CRISTOL, PUPH, jp-cristol@chu-montpellier.fr
Vincent DELATOUR, Dr, Vincent.delatour@lne.fr
About this study
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.
Read more
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.
Read the 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 biology tests are central to clinical decision-making and must deliver reliable, accurate, reproducible, and standardized results across all medical laboratories.
Under Regulation (EU) 2017/746, the metrological traceability of values assigned to calibrators and quality control materials must be ensured through Reference Measurement Procedures (RMPs) and/or Certified Reference Materials (CRMs) of higher order. However, among the thousands of parameters routinely measured, fewer than 200 currently meet these requirements, making regulatory compliance difficult for IVD manufacturers and limiting laboratories' ability to meet ISO NF 15189 standards.
It is therefore essential to develop CRMs and External Quality Controls (EQA) that are compatible with high-throughput multiparameter analyzers used in medical laboratories. These materials must not only be traceable but also commutable, meaning they must behave similarly to native patient samples to ensure analytical validity.
The COMET-MPL project addresses this need by evaluating the interchangeability (commutability) of selected CRMs and EQA integrated into multiparametric preparations. These will be tested on automated high-throughput systems used in routine medical biology laboratories to assess their suitability as calibrators or quality controls under real-world conditions.
Each patient will participate in a single visit, during a scheduled blood draw as part of routine care. Three blood tubes will be collected, the serum will be aliquoted, and samples will be sent to partner laboratories for analysis.
The collective benefits of this study include:
- Improved patient care pathways, from initial diagnosis to therapeutic follow-up, through enhanced analytical quality of laboratory tests.
- Strengthened regulatory compliance for laboratories and IVD manufacturers.
- Availability of high metrological quality CRMs and EQA, facilitating alignment with ISO standards 15189.
- Greater reliability and comparability of biological results, contributing to more precise and equitable healthcare delivery.
- Conditions
- Hospitalization, All Conditions
- Keywords
- In Vitro Diagnostics (IVD), Commutability, Calibration, Interchangeability, Analytical Validity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (17)
Serum Testosterone Concentration
Measured concentration (ng/dL) in patient serum samples using standardized laboratory methods
Measured: 1 day
Serum Calcium Concentration
Measured concentration (mg/dL) in patient serum samples using standardized laboratory methods
Measured: 1 day
Serum Glucose Concentration
Measured concentration (mg/dL) in patient serum samples using standardized laboratory methods
Measured: 1 day
Total Cholesterol Concentration
Measured concentration (mg/dL) in patient serum samples using standardized laboratory methods
Measured: 1 day
High-Density Lipoprotein Cholesterol (HDL-C) Concentration
Measured concentration (mg/dL) in patient serum samples using standardized laboratory methods
Measured: 1 day
Triglyceride (TG) Concentration
Measured concentration (mg/dL) in patient serum samples using standardized laboratory methods
Measured: 1 day
Alanine Aminotransferase (ALT) Activity
Measured concentration (U/L) in patient serum samples using standardized laboratory methods
Measured: 1 day
Creatine Kinase (CK) Activity
Measured concentration (U/L) in patient serum samples using standardized laboratory methods
Measured: 1 day
Serum Albumin Concentration
Measured concentration (g/dL) in patient serum samples using standardized laboratory methods
Measured: 1 day
Non-commutability bias of certified reference materials (CRMs) consisting of Lyophilized serum spiked with exogenous compounds
measured (in %) by establishing difference plots between biochemical measurement results obtained for the CRMs and a panel of clinical specimens (see Clin Chem. 2018;64(3):455-464)
Measured: 1 day
Non-commutability bias of certified reference materials (CRMs) consisting of Lyophilized serum not spiked with exogenous compounds
measured (in %) by establishing difference plots between biochemical measurement results obtained for the CRMs and a panel of clinical specimens (see Clin Chem. 2018;64(3):455-464)
Measured: 1 day
Non-commutability bias of certified reference materials (CRMs) consisting of frozen serum spiked with exogenous compounds
measured (in %) by establishing difference plots between biochemical measurement results obtained for the CRMs and a panel of clinical specimens (see Clin Chem. 2018;64(3):455-464)
Measured: 1 day
Non-commutability bias of certified reference materials (CRMs) consisting of frozen serum not spiked with exogenous compounds
measured (in %) by establishing difference plots between biochemical measurement results obtained for the CRMs and a panel of clinical specimens (see Clin Chem. 2018;64(3):455-464)
Measured: 1 day
Non-commutability bias of external quality controls (EQA) consisting of Lyophilized serum spiked with exogenous compounds
Measured (in %) by establishing difference plots between biochemical measurement results obtained for the EQA and a panel of clinical specimens (see Clin Chem. 2018;64(3):455-464).
Measured: 1 day
Non-commutability bias of external quality controls (EQA) consisting of Lyophilized serum not spiked with exogenous compounds
Measured (in %) by establishing difference plots between biochemical measurement results obtained for the EQA and a panel of clinical specimens (see Clin Chem. 2018;64(3):455-464).
Measured: 1 day
Non-commutability bias of external quality controls (EQA) consisting of frozen serum spiked with exogenous compounds
Measured (in %) by establishing difference plots between biochemical measurement results obtained for the EQA and a panel of clinical specimens (see Clin Chem. 2018;64(3):455-464).
Measured: 1 day
Non-commutability bias of external quality controls (EQA) consisting of frozen serum not spiked with exogenous compounds
Measured (in %) by establishing difference plots between biochemical measurement results obtained for the EQA and a panel of clinical specimens (see Clin Chem. 2018;64(3):455-464).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start22 Sep 2025
- Primary completion22 Sep 2026 (estimated)
- Study completion22 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HospitalizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul CRISTOL, PUPH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173114
- Sponsor's protocol ID
- RECHMPL24_0369
- Acronym
- COMET-MPL
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Approaches for Evaluating the Interchangeability of Reference Materials and Quality Controls (COMET-MPL)
- ClinicalTrials.gov ID
- NCT07173114
- Acronym / sponsor ID
- COMET-MPL / RECHMPL24_0369
- Conditions
- Hospitalization, All Conditions
- Keywords
- In Vitro Diagnostics (IVD), Commutability, Calibration, Interchangeability, Analytical Validity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 22 Sep 2026 (estimated)
- Study completion
- 22 Sep 2026 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 biology tests are central to clinical decision-making and must deliver reliable, accurate, reproducible, and standardized results across all medical laboratories.
Under Regulation (EU) 2017/746, the metrological traceability of values assigned to calibrators and quality control materials must be ensured through Reference Measurement Procedures (RMPs) and/or Certified Reference Materials (CRMs) of higher order. However, among the thousands of parameters routinely measured, fewer than 200 currently meet these requirements, making regulatory compliance difficult for IVD manufacturers and limiting laboratories' ability to meet ISO NF 15189 standards.
It is therefore essential to develop CRMs and External Quality Controls (EQA) that are compatible with high-throughput multiparameter analyzers used in medical laboratories. These materials must not only be traceable but also commutable, meaning they must behave similarly to native patient samples to ensure analytical validity.
The COMET-MPL project addresses this need by evaluating the interchangeability (commutability) of selected CRMs and EQA integrated into multiparametric preparations. These will be tested on automated high-throughput systems used in routine medical biology laboratories to assess their suitability as calibrators or quality controls under real-world conditions.
Each patient will participate in a single visit, during a scheduled blood draw as part of routine care. Three blood tubes will be collected, the serum will be aliquoted, and samples will be sent to partner laboratories for analysis.
The collective benefits of this study include:
- Improved patient care pathways, from initial diagnosis to therapeutic follow-up, through enhanced analytical quality of laboratory tests.
- Strengthened regulatory compliance for laboratories and IVD manufacturers.
- Availability of high metrological quality CRMs and EQA, facilitating alignment with ISO standards 15189.
- Greater reliability and comparability of biological results, contributing to more precise and equitable healthcare delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population consists of patients hospitalized in the departments of the investigative teams at Montpellier University Hospital, regardless of their pathologies.
Key inclusion criteria (2 listed)
- Panel 1: adults ≥ 18 years of age.
- Panel 2: adults ≥ 18 years of age undergoing immunosuppressive treatment (cyclosporine, everolimus, tacrolimus, sirolimus).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Commutability
Time frame: 1 day
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.
17 secondary outcomes
Serum Testosterone Concentration
Time frame: 1 day
Serum Calcium Concentration
Time frame: 1 day
Serum Glucose Concentration
Time frame: 1 day
Total Cholesterol Concentration
Time frame: 1 day
High-Density Lipoprotein Cholesterol (HDL-C) Concentration
Time frame: 1 day
Triglyceride (TG) Concentration
Time frame: 1 day
Alanine Aminotransferase (ALT) Activity
Time frame: 1 day
Creatine Kinase (CK) Activity
Time frame: 1 day
Serum Albumin Concentration
Time frame: 1 day
Non-commutability bias of certified reference materials (CRMs) consisting of Lyophilized serum spiked with exogenous compounds
Time frame: 1 day
Non-commutability bias of certified reference materials (CRMs) consisting of Lyophilized serum not spiked with exogenous compounds
Time frame: 1 day
Non-commutability bias of certified reference materials (CRMs) consisting of frozen serum spiked with exogenous compounds
Time frame: 1 day
Non-commutability bias of certified reference materials (CRMs) consisting of frozen serum not spiked with exogenous compounds
Time frame: 1 day
Non-commutability bias of external quality controls (EQA) consisting of Lyophilized serum spiked with exogenous compounds
Time frame: 1 day
Non-commutability bias of external quality controls (EQA) consisting of Lyophilized serum not spiked with exogenous compounds
Time frame: 1 day
Non-commutability bias of external quality controls (EQA) consisting of frozen serum spiked with exogenous compounds
Time frame: 1 day
Non-commutability bias of external quality controls (EQA) consisting of frozen serum not spiked with exogenous compounds
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent DELATOUR, Dr contact
Jean-Paul CRISTOL, PUPH principal investigator
University Hospital, Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalization and All Conditions, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Paul CRISTOL, PUPH (+33 0467338314, jp-cristol@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Commutability (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.