Validation of the Stability of Diagnostic Biomarkers on Healthy Volunteers

Recruiting now · Not applicable

Conditions studied: Healthy

In brief

Stability studies on the peripheral biomarkers (lncRNAs, sncRNAs, mRNAs, proteins, lipids/metabolites) measured by Firalis IVD test candidates and effect of gender, age, nutrition on their expression level

Key facts

Study ID

NCT05160337

Run by

Firalis SA

People needed

60

Starts

2025-06-18

Expected to finish

2027-04-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Firalis Clinical Investigation Center — Huningue, France (enrolling)

Full record on ClinicalTrials.gov

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