What is this study trying to find out about diagnostic biomarkers?

This study aims to evaluate the stability and expression levels of various diagnostic biomarkers in healthy volunteers. Researchers are studying how factors like age, gender, and nutrition affect these biomarkers measured by Firalis IVD tests. Firalis SA sponsors this research to support the development of diagnostic tools for major diseases.

Who may be eligible for this healthy volunteer clinical trial?

Adults aged 18 to 85 years who are healthy with no apparent disease may be eligible. Both men and women can participate if they meet weight requirements and have no major mental or physical disabilities. Please review eligibility criteria for more details.

Is there any cost to participate in this healthy volunteer clinical trial?

Study-related care, including diagnostic testing and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 85Years

All Genders

Healthy Volunteers

ID05160337

Study on the Stability of Diagnostic Biomarkers in Healthy Adults Using Firalis IVD Tests

Led by Firalis SA · Updated on 2026-06-24

Participants Needed

Research Sites

34 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to validate the stability of various diagnostic biomarkers measured by Firalis IVD tests in healthy volunteers. The study focuses on biomarkers such as long non-coding RNAs lncRNAs, small non-coding RNAs sncRNAs, messenger RNAs mRNAs, proteins, lipids, and metabolites, also examining the effects of gender, age, and nutrition on these markers. Firalis SA and its affiliate Amoneta Diagnostics SAS are developing these tests for major diseases including cardiovascular and neurodegenerative disorders, supporting the analytical validation phase of their diagnostic tools. Participants in this study will undergo biomarker-based in-vitro diagnostic IVD tests developed by Firalis. The tests involve collecting biological samples to analyze the expression levels of these biomarkers under different conditions, such as before and after breakfast intake. This study includes a single group of healthy volunteers, and the focus is on stability and expression level assessments rather than treatment or intervention. The study does not involve medication or placebo but collects data to support diagnostic test validation. During the study, participants will provide biological samples at baseline fasting, before breakfast and then again one hour after breakfast to measure biomarker expression. Researchers will analyze the expression of lncRNAs, sncRNAs, mRNAs, and soluble proteins at these timepoints. The study also considers factors like age, gender, nutrition, and time intervals between sample collections. Participant involvement includes signing informed consent, complying with study procedures, and attending scheduled sample collection visits. The study duration extends until April 2027, with the primary outcome measured by biomarker expression changes before and after breakfast.

CONDITIONS

Brief Title

Validation of the Stability of Diagnostic Biomarkers on Healthy Volunteers

Who Can Participate

Age: 18Years - 85Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

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 will not qualify if you...

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.

Research Team

Federica ZILLI, PhD

Hueseyin Firat, MD, PhD, HDR

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Study on the Stability of Diagnostic Biomarkers in Healthy Adults Using Firalis IVD Tests

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria