REF-VALUE Study: Establishment of Reference Values for Biomarkers in Healthy Adults

NCT07666191 | Not Yet Recruiting

• 1 other identifier: 69HCL26_0579
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Uninfected Healthy Adult Subjects

Keywords

Type I Interferon Response; Healthy volunteers; Reference value

Outcome Measures

Primary Outcomes (1)

• 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.

  One day

Secondary Outcomes (4)

• To assess the impact of immune parameters on baseline blood and nasal IFN-I scores

  One day

• To assess the impact of demographic and clinical parameters on baseline blood and nasal IFN-I scores

  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

  One day

• Establishment of a biobank

  One day

Study Arms (1)

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.

Biological: Biological Sampling

Interventions

Biological Sampling BIOLOGICAL

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).

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged between 18 and 65 years (inclusive)
• Participants with no known medical conditions
• Body weight of 50 kg or more

You may not qualify if:

• Participants with symptoms of an active infection (symptom questionnaire or temperature \> 37.5°C).
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Officials

• Sophie TROUILLET-ASSANT

  Laboratoire Commun de Recherche, Hôpital Lyon Sud, Hospices Civils de Lyon, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie TROUILLET-ASSANT

CONTACT

+33 4 72 67 87 80; sophie.trouillet-assant@chu-lyon.fr

William MOUTON

CONTACT

+33 4 72 67 87 85; william.mouton@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, prospective, interventional study with minimal risk and constraints, RIPH category 2 outside of healthcare product

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06