Validation of the Stability of Diagnostic Biomarkers on Healthy Volunteers

Clinical Study on Healthy Volunteers for Validating the Stability of Different Diagnostic Biomarkers Studied at Firalis

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Diagnostic test: Biomarker based IVD tests

Detailed Description

Firalis SA and its affiliate Amoneta Diagnostics SAS are developing novel in-vitro diagnostic (IVD) tests for diverse diagnostic applications for major human diseases, including cardiovascular, and neurodegenerative disorders. These tests measure in blood and other peripheral body fluids; long non-coding RNAs (lncRNAs), small non-coding RNAs (sncRNAs), messenger RNAs (mRNAs), circulating proteins, lipids and metabolites. In addition, since 2020, Firalis is producing the salivary test EasyCOV for detection of Covid-19 positivity in both symptomatic and asymptomatic subjects. Firalis group is the sponsor of a pipeline of various clinical studies conducted in diverse National and European clinical sites of excellence, enrolling patients affected by the targeted diseases studied such as acute myocardial injury, Alzheimer disease for the proof of performance phase of the biomarkers and IVD test candidates. The present specific study aims to collect biological samples to complete the analytical validation of its diverse IVD tools namely the evaluation of the stability of the biomarkers and the effect of age, gender, nutrition and inter-period on the expression level of the studied biomarkers.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodwell Mkhwananzi, LD; Phone Number: 0389911320; Email: rodwell.mkhwananzi@firalis.com

Study Locations

• France
  • Huningue, France, 68330
    • Firalis Clinical Investigation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Healthy Volunteers; Healthy Volunteers will be recruited into the study	Diagnostic test: Biomarker based IVD tests; Biomarker based IVD tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lncRNA Biomarker expression before breakfast intake	lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples	T0- Baseline in the morning before breakfast at fasting conditions
lncRNA Biomarker expression after breakfast intake	lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples	T1- 1 hour after breakfast

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sncRNA Biomarker expression before breakfast intake	sncRNA expression in count per million measured in blood plasma and whole blood paxgene samples	T0- Baseline in the morning before breakfast at fasting conditions
sncRNA Biomarker expression after breakfast intake	sncRNA expression in count per million measured in blood plasma and whole blood paxgene samples	T1- 1 hour after breakfast
mRNAs Biomarker expression before breakfast intake	mRNAs expression in count per million measured in blood plasma and whole blood samples	T0- Baseline in the morning before breakfast at fasting conditions
mRNAs Biomarker expression after breakfast intake	mRNAs expression in count per million measured in blood plasma and whole blood samples	T1- 1 hour after breakfast
Soluble proteins Biomarker expression before breakfast intake	Soluble proteins expression in ng/mL measured in blood plasma and urine samples	T0- Baseline in the morning before breakfast at fasting conditions
Soluble proteins Biomarker expression after breakfast intake	Soluble proteins expression in ng/mL measured in blood plasma and urine samples	T1- 1 hour after breakfast

Collaborators and Investigators

• Sponsor: Firalis SA
• Investigators: Principal Investigator: Pierre Rohrlich, Phd, Firalis SA

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): April 1, 2023

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (ACTUAL): December 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: biomarkers; chronobiology; healthy volounteers; diagnostic biomarkers
• Other Study ID Numbers: 2021-A00405-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No