A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis (ApoDiag)

April 29, 2025 updated by: Firalis SA

ApoDiag: A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis

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 detect several gene mutations related to the above-mentioned pathologies. The development of IVD tools requires the evaluation of analytical parameters including biomarker stability.

The present specific study therefore aims to collect whole blood samples in PAXgene DNA tubes to complete the analytical validation of IVD tools and the evaluation of the stability of the DNA in PAXgene DNA tubes and the reagents in the IVD tools.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1474

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54100
        • EFS GEST
      • Strasbourg, France, 67000
        • EFS GEST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy donors

Description

Inclusion Criteria:

  • Donors who sign the informed consent forms for sample collection and for genotyping.
  • Adults, both genders, aged 18-85 years.
  • Not under any administrative or legal supervision

Exclusion Criteria:

  • Anyone who did not sign the Informed Consent form.
  • Subjects aged below 18 years and older than 85 years are excluded.
  • Pregnant, parturient and nursing women are excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
APOE E
The cohort will be genotyped to determine the phenotype of the APOE allele
Diagnostic test: APO-Easy
Testing for the APOE genotype using the APO-Easy Genotyping test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
APOE Genotype
Time Frame: Baseline
Blood samples will be collected to establish the feasibility of detecting several gene mutations associated with the risk of Alzheimer's disease/ Cardiovascular disorder and validation of analytical parameters
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specimen stability
Time Frame: Baseline, 24hrs, 5 days, 28 days, 3 months, 12 months, 24 months
Blood samples will be collected to establish the stability of PAXgene DNA samples at different timepoints after storage at -20° and -80°C.
Baseline, 24hrs, 5 days, 28 days, 3 months, 12 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firalis SA

Investigators

  • Study Director: Huseyin Firat, MD PhD, Firalis SA
  • Study Chair: Lucas Pham-Van, PhD, Firalis SA
  • Study Chair: Joanna Michel, Firalis SA
  • Study Director: Sthepanie Boutillier, PhD, Firalis SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Actual)

March 25, 2025

Study Completion (Actual)

March 25, 2025

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-A02120-45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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