Stability of diagnostic blood and saliva biomarkers in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.