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

NCT06432192 | Completed

• 1 other identifier: 2023-A02120-45
• Study Type: observational
• Target: 1,474
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Genetic Health Risks

Keywords

Polygenic risk; APOE, Apolipoprotein; Neurodegenerative disorders; Dementia; Alzheimer disease; Genetic risks

Outcome Measures

Primary Outcomes (1)

• APOE Genotype

  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 Outcomes (1)

• Specimen stability

  Baseline, 24hrs, 5 days, 28 days, 3 months, 12 months, 24 months

Study Arms (1)

APOE E

The cohort will be genotyped to determine the phenotype of the APOE allele

Diagnostic Test: APO-Easy

Interventions

APO-Easy DIAGNOSTIC_TEST

Testing for the APOE genotype using the APO-Easy Genotyping test

APOE E

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy donors

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Firalis SA: lead

Study Sites (2)

EFS GEST

Nancy, 54100, France

Location

EFS GEST

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Neurodegenerative Diseases; Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies

Study Officials

• Huseyin Firat, MD PhD

  Firalis SA

  STUDY DIRECTOR

• Lucas Pham-Van, PhD

  Firalis SA

  STUDY CHAIR

• Joanna Michel

  Firalis SA

  STUDY CHAIR

• Sthepanie Boutillier, PhD

  Firalis SA

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: January 2, 2024
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: April 30, 2025

Record last verified: 2024-09

Locations

FR (2)