Health TrialsbyHealthPanel

Validation of the Stability of Diagnostic Biomarkers on Healthy Volunteers

ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFiralis SA

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Biomarker based IVD tests

    Diagnostic test

    Biomarker based IVD tests

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Healthy VolunteersOther 1 intervention

Trial outcomes

Primary outcomes

1

lncRNA Biomarker expression before breakfast intake

lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples

Time frame
T0- Baseline in the morning before breakfast at fasting conditions
2

lncRNA Biomarker expression after breakfast intake

lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples

Time frame
T1- 1 hour after breakfast

Secondary outcomes

1

sncRNA Biomarker expression before breakfast intake

sncRNA cycle threshold measured in blood plasma

Time frame
T0- Baseline in the morning before breakfast at fasting conditions
2

sncRNA Biomarker expression after breakfast intake

sncRNA cycle threshold measured in blood plasma

Time frame
T1- 1 hour after breakfast
3

mRNAs Biomarker expression before breakfast intake

mRNAs cycle threshold measured in blood plasma

Time frame
T0- Baseline in the morning before breakfast at fasting conditions
4

mRNAs Biomarker expression after breakfast intake

mRNAs cycle threshold measured in blood plasma

Time frame
T1- 1 hour after breakfast

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Firalis SA

Lead sponsor

Source ClinicalTrials.gov
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