Stability of diagnostic blood and saliva biomarkers in healthy adults
Clinical Study on Healthy Volunteers for Validating the Stability of Different Diagnostic Biomarkers Studied at Firalis
This tests whether different blood and saliva biomarkers (lncRNAs, sncRNAs, mRNAs, proteins, lipids, metabolites) stay stable over time in healthy adults and whether age, sex, or recent nutrition change their levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Firalis SA Industry-sponsored |
| Locations | 1 site (Huningue) |
| Trial ID | NCT05160337 on ClinicalTrials.gov |
What this trial studies
Firalis will enroll healthy volunteers aged 18–85 to provide blood and other peripheral samples at its Clinical Investigation Center in Huningue. Collected samples will be anonymized and analyzed for long non-coding RNAs, small non-coding RNAs, messenger RNAs, circulating proteins, lipids, and metabolites to measure stability across repeat collection times. The study will record participant age, sex, and recent nutritional status to determine how these factors influence biomarker expression. Results will be used for the analytical validation of Firalis' in‑vitro diagnostic test candidates.
Who should consider this trial
Good fit: Healthy adults 18–85 who can give informed consent, comply with study procedures, and meet the minimum weight thresholds (males >50 kg, females >40 kg) are the ideal participants.
Not a fit: Individuals with active medical conditions, those seeking therapeutic benefit, minors, or people unable to travel to the single Huningue site will not receive direct clinical benefit from participating.
Why it matters
Potential benefit: If successful, the results could improve the reliability and clinical readiness of Firalis' diagnostic tests by identifying which biomarkers are stable and how demographic or dietary factors affect measurements.
How similar studies have performed: Biomarker stability and preanalytic effect studies are a common, established part of diagnostic validation and have been used successfully in prior diagnostic development programs.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants who sign the informed consent forms for sample collection and data collection both anonymized and reported in CRF. * Able to comply with all study procedures. * Healthy Volunteers having no apparent disease. * Adults, both genders, aged 18-85 years. * Participants with no apparent motor or mental health abnormality. * Participants having no major disabling mental or physical disability that would require hospitalization. * Body weight above 50 kg if male, above 40 kg if female. Exclusion Criteria: * Any subject who did not sign the Informed Consent form. * Any subject who, in the judgment of the Investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development. * Any subject in the exclusion period of a previous study according to applicable regulations. * Any subject who cannot be contacted in case of emergency. * Any subject who is the Investigator or any sub-investigator, research assistant, study coordinator, or other staff thereof, directly involved in the conduct of the protocol. * Any subject with a disease that, in the judgement of the investigator, would interfere with the conduct of study or harm the safety of volunteer. * Subjects with disabling disease or abnormal health status are excluded. * Subjects aged below 18 years and older than 85 years are excluded. * Pregnant, parturient and nursing women are excluded. * Subjects deprived of their liberty by a judicial or administrative decision, protected adults and vulnerable persons are excluded. * Subjects who are under legal protection or who are unable to express their consent are not included. * Any subject who reports in the questionnaire of the screening period having one of the following diseases is excluded: * Any psychiatric or neurodegenerative disease or neurologic disorder. * Hypertension. * Any cardiovascular disease. * Any chronic inflammatory disease such as rheumatoid arthritis. * Any cancer. * Frequent headaches and/or migraine, recurrent nausea and/or vomiting. * Any subject who did a blood donation, any volume, within 2 months before inclusion. * Any subject who reports in the questionnaire of the screening period having medication(s) for one or more of the above diseases is excluded. * Drug or alcohol abuse or smoking more than 10 cigarettes or equivalent. * Subjects with no apparent disease and symptoms, but with unknown Covid-19 positivity are not excluded.
Where this trial is running
Huningue
- Firalis Clinical Investigation Center — Huningue, France (Recruiting)
Study contacts
- Principal investigator: Pierre Rohrlich, MD,Phd — Firalis SA
- Study coordinator: Federica ZILLI, PhD
- Email: clinical@firalis.com
- Phone: 0389911320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.