Uninfected Healthy Adult SubjectsREF-VALUE StudNCT07666191
REF-VALUE Study: Establishment of Reference Values for Biomarkers in Healthy Adults
A study testing Biological Sampling in people with Uninfected Healthy Adult Subjects, run by Hospices Civils de Lyon.
Trial summary
Circulating biomarkers play a central role in translational research and precision medicine, particularly for the diagnosis, prognostic, monitoring of inflammatory or infectious diseases and patient stratification. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Uninfected Healthy Adult Subjects
- What is being tested?
- Biological Sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Aug 2027
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants aged between 18 and 65 years (inclusive)
- Participants with no known medical conditions
- Body weight of 50 kg or more
Who cannot join
- Participants with symptoms of an active infection (symptom questionnaire or temperature > 37.5°C).
- Subjects participating in another interventional study with an exclusion period that is still ongoing or that may interfere with this protocol
- Pregnant women, women in labour or breastfeeding women
- Individuals deprived of their liberty by a judicial or administrative decision
- Individuals receiving psychiatric care
- Individuals admitted to a health or social care facility for purposes other than research
- Adults subject to legal protection measures (guardianship, curatorship)
- Individuals not affiliated with a social security scheme or beneficiaries of a similar scheme
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Circulating biomarkers play a central role in translational research and precision medicine, particularly for the diagnosis, prognostic, monitoring of inflammatory or infectious diseases and patient stratification. Advances in analytical technologies enable standardised, sensitive and multiplexed assays, but their application remains limited by the lack of reliable reference values derived from well-characterised healthy populations. Indeed, the available data are often heterogeneous and difficult to transfer between platforms.
In this context, the establishment of institutional reference cohorts appears essential for the correct interpretation of immunological parameters-which could be strongly influenced by demographic and clinical factors-and for defining relevant cut-off values when identifying new biomarkers of interest. This issue is particularly critical in the field of viral respiratory infections, where current diagnostic approaches still have several limitations.
Read more
Circulating biomarkers play a central role in translational research and precision medicine, particularly for the diagnosis, prognostic, monitoring of inflammatory or infectious diseases and patient stratification. Advances in analytical technologies enable standardised, sensitive and multiplexed assays, but their application remains limited by the lack of reliable reference values derived from well-characterised healthy populations. Indeed, the available data are often heterogeneous and difficult to transfer between platforms.
In this context, the establishment of institutional reference cohorts appears essential for the correct interpretation of immunological parameters-which could be strongly influenced by demographic and clinical factors-and for defining relevant cut-off values when identifying new biomarkers of interest. This issue is particularly critical in the field of viral respiratory infections, where current diagnostic approaches still have several limitations.
Diagnosis is usually based on PCR tests targeting the DNA or RNA of pathogens, requiring a virus-specific test. In practice, only a few viruses (SARS-CoV-2, RSV, influenza) are tested for as a first-line investigation, whilst many other agents may be involved. As a comprehensive approach is difficult to achieve, viral infections often remain under-reported.
Furthermore, the detection of a virus by PCR may indicate either an active infection or residual traces of a past infection. Although viral load can aid interpretation, it does not always allow for a definitive conclusion, making it difficult to distinguish between ongoing viral replication and the persistence of genetic material. It is therefore necessary to have additional markers associated with active infection.
In this context, analysing the host response represents a promising alternative. Viruses induce, in particular, the production of type I interferons (IFN-I), the measurement of which could point the diagnosis towards a viral origin and reflect ongoing infectious activity. However, the interpretation of these biomarkers requires robust reference standards, taking into account their variability across individuals and contexts.
Several studies illustrate the value of such approaches, such as the REFIPA study (NCT07239830), conducted in subjects over 80 years of age, which aims to characterise the immune response, particularly IFN-I, in the context of immunosenescence. This type of study highlights the need for well-phenotyped healthy ? control populations according to age groups and clinical contexts.
Finally, beyond the creation of reference databases, the development of biobanks appears essential. This would enable the establishment of harmonised and directly usable reference values, thereby facilitating translational, basic and pre-clinical research projects, as well as the identification and validation of new biomarkers.
- Conditions
- Uninfected Healthy Adult Subjects
- Being tested
- Biological Sampling
- Keywords
- Type I Interferon Response, Healthy volunteers, Reference value
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological SamplingBiological
The procedures specifically carried out for the study are as follows:
- 1 nasopharyngeal swab for baseline measurement of the nasal IFN score and to detect the presence of infection
- Venous blood sample collection:
- 1 x 2.5 mL PAXgene tube for baseline measurement of the blood IFN score
- 1 x 4 mL dry tube (serum) to quantify anti-IFN antibody levels
- 1 x 4 mL heparinized tube to assess non-specific functional immunity.
- 1 x 2 mL EDTA tube for quantification of circulating leukocyte populations via complete blood count (CBC)
- 1 x 2 mL EDTA tube for quantification of the main circulating lymphocyte subpopulations via immunophenotyping
- 2 x 10 mL EDTA tubes and 1 x 4 mL EDTA tube for collection of PBMCs and plasma for biobanking A total of 38.5 mL of venous blood will be collected for the study during a single visit. This volume complies with regulations for subjects weighing at least 50 kg (eligibility criterion).
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Healthy, uninfected adults aged 18 to 65 inclusive. Participants may be recruited through the press and social media, via the staff mailing list of the Hospices Civils de Lyon, or via posters displayed within the hospital aimed at staff, as well as at patients' carers and any other interested individuals. Receives: Biological: Biological Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish reference values for the nasal and blood type I interferon score in an uninfected adult population aged 18 to 65 years inclusive.
The primary endpoint is the measurement of nasal and blood interferon levels in a population of uninfected adults aged 18 to 65 years inclusive.
Measured: One day
Secondary outcomes (4)
To assess the impact of immune parameters on baseline blood and nasal IFN-I scores
Correlation between immune parameters assessed by anti-IFN antibody concentration, the abundance of key immune cell subpopulations, lymphocyte function assessed by functional immune testing (such as IGRA), and the baseline blood and nasal interferon score
Measured: One day
To assess the impact of demographic and clinical parameters on baseline blood and nasal IFN-I scores
Correlation between demographic (age, sex) and clinical parameters, and the baseline blood and nasal interferon score
Measured: One day
Compare baseline IFN-I levels between two subgroups of participants initially considered uninfected: those in whom the PCR test routinely performed on the day of the visit detects no infection, and those in whom this PCR test reveals an asymptomatic infe
Mean (or median) variation in IFN-I between the two groups, with estimation of the effect size (confidence interval) and the level of statistical significance.
Measured: One day
Establishment of a biobank
Establishment of a biobank
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uninfected Healthy Adult SubjectsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, prospective, interventional study with minimal risk and constraints, RIPH category 2 outside of healthcare product
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie TROUILLET-ASSANT, Principal investigator, Laboratoire Commun de Recherche, Hôpital Lyon Sud, Hospices Civils de Lyon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666191
- Sponsor's protocol ID
- 69HCL26_0579
- Acronym
- REF-VALUE Stud
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REF-VALUE Study: Establishment of Reference Values for Biomarkers in Healthy Adults
- ClinicalTrials.gov ID
- NCT07666191
- Acronym / sponsor ID
- REF-VALUE Stud / 69HCL26_0579
- Conditions
- Uninfected Healthy Adult Subjects
- Keywords
- Type I Interferon Response, Healthy volunteers, Reference value
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 24 Jun 2026 (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.
Circulating biomarkers play a central role in translational research and precision medicine, particularly for the diagnosis, prognostic, monitoring of inflammatory or infectious diseases and patient stratification. Advances in analytical technologies enable standardised, sensitive and multiplexed assays, but their application remains limited by the lack of reliable reference values derived from well-characterised healthy populations. Indeed, the available data are often heterogeneous and difficult to transfer between platforms.
In this context, the establishment of institutional reference cohorts appears essential for the correct interpretation of immunological parameters-which could be strongly influenced by demographic and clinical factors-and for defining relevant cut-off values when identifying new biomarkers of interest. This issue is particularly critical in the field of viral respiratory infections, where current diagnostic approaches still have several limitations.
Circulating biomarkers play a central role in translational research and precision medicine, particularly for the diagnosis, prognostic, monitoring of inflammatory or infectious diseases and patient stratification. Advances in analytical technologies enable standardised, sensitive and multiplexed assays, but their application remains limited by the lack of reliable reference values derived from well-characterised healthy populations. Indeed, the available data are often heterogeneous and difficult to transfer between platforms.
In this context, the establishment of institutional reference cohorts appears essential for the correct interpretation of immunological parameters-which could be strongly influenced by demographic and clinical factors-and for defining relevant cut-off values when identifying new biomarkers of interest. This issue is particularly critical in the field of viral respiratory infections, where current diagnostic approaches still have several limitations.
Diagnosis is usually based on PCR tests targeting the DNA or RNA of pathogens, requiring a virus-specific test. In practice, only a few viruses (SARS-CoV-2, RSV, influenza) are tested for as a first-line investigation, whilst many other agents may be involved. As a comprehensive approach is difficult to achieve, viral infections often remain under-reported.
Furthermore, the detection of a virus by PCR may indicate either an active infection or residual traces of a past infection. Although viral load can aid interpretation, it does not always allow for a definitive conclusion, making it difficult to distinguish between ongoing viral replication and the persistence of genetic material. It is therefore necessary to have additional markers associated with active infection.
In this context, analysing the host response represents a promising alternative. Viruses induce, in particular, the production of type I interferons (IFN-I), the measurement of which could point the diagnosis towards a viral origin and reflect ongoing infectious activity. However, the interpretation of these biomarkers requires robust reference standards, taking into account their variability across individuals and contexts.
Several studies illustrate the value of such approaches, such as the REFIPA study (NCT07239830), conducted in subjects over 80 years of age, which aims to characterise the immune response, particularly IFN-I, in the context of immunosenescence. This type of study highlights the need for well-phenotyped healthy ? control populations according to age groups and clinical contexts.
Finally, beyond the creation of reference databases, the development of biobanks appears essential. This would enable the establishment of harmonised and directly usable reference values, thereby facilitating translational, basic and pre-clinical research projects, as well as the identification and validation of new biomarkers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, prospective, interventional study with minimal risk and constraints, RIPH category 2 outside of healthcare product
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Biological: Biological SamplingHealthy, uninfected adults aged 18 to 65 inclusive. Participants may be recruited through the press and social media, via the staff mailing list of the Hospices Civils de Lyon, or via posters displayed within the hospital aimed at staff, as well as at patients' carers and any other interested individuals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants aged between 18 and 65 years (inclusive)
- Participants with no known medical conditions
- Body weight of 50 kg or more
Key exclusion criteria (8 listed)
- Participants with symptoms of an active infection (symptom questionnaire or temperature > 37.5°C).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological SamplingThe procedures specifically carried out for the study are as follows: * 1 nasopharyngeal swab for baseline measurement of the nasal IFN score and to detect the presence of infection * Venous blood sample collection: * 1 x 2.5 mL PAXgene tube for baseline measurement of the blood IFN score * 1 x 4 mL dry tube (serum) to quantify anti-IFN antibody levels * 1 x 4 mL heparinized tube to assess non-specific functional immunity. * 1 x 2 mL EDTA tube for quantification of circulating leukocyte populations via complete blood count (CBC) * 1 x 2 mL EDTA tube for quantification of the main circulating lymphocyte subpopulations via immunophenotyping * 2 x 10 mL EDTA tubes and 1 x 4 mL EDTA tube for collection of PBMCs and plasma for biobanking A total of 38.5 mL of venous blood will be collected for the study during a single visit. This volume complies with regulations for subjects weighing at least 50 kg (eligibility criterion). | Biological | Healthy volunteers |
Primary outcome
To establish reference values for the nasal and blood type I interferon score in an uninfected adult population aged 18 to 65 years inclusive.
Time frame: One day
The primary endpoint is the measurement of nasal and blood interferon levels in a population of uninfected adults aged 18 to 65 years inclusive.
4 secondary outcomes
To assess the impact of immune parameters on baseline blood and nasal IFN-I scores
Time frame: One day
To assess the impact of demographic and clinical parameters on baseline blood and nasal IFN-I scores
Time frame: One day
Compare baseline IFN-I levels between two subgroups of participants initially considered uninfected: those in whom the PCR test routinely performed on the day of the visit detects no infection, and those in whom this PCR test reveals an asymptomatic infe
Time frame: One day
Establishment of a biobank
Time frame: One 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 24 Jun 2026.
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.
Sophie TROUILLET-ASSANT principal investigator
Laboratoire Commun de Recherche, Hôpital Lyon Sud, Hospices Civils de Lyon, France
Questions about this trial
What is this clinical trial studying?
A study testing Biological Sampling in people with Uninfected Healthy Adult Subjects, run by Hospices Civils de Lyon.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Sophie TROUILLET-ASSANT (+33 4 72 67 87 80, sophie.trouillet-assant@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish reference values for the nasal and blood type I interferon score in an uninfected adult population aged 18 to 65 years inclusive. (time frame: One 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 24 Jun 2026.