NCT06432192Completed
A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis
ApoDiag: A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis
Source: ClinicalTrials.gov · Last updated 30 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1474 (actual)
- First submitted
- 22 May 2024
- Start date
- 2 Jan 2024
- Primary completion date
- 25 Mar 2025
- Lead sponsor
- Firalis SA
- Diseases
- Alzheimer disease
- NCT number
- NCT06432192
What you commit to
- Study type: Observational
- Participants enrolled: 1474
- From 2 Jan 2024 to the primary completion date, 25 Mar 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Subjects aged below 18 years and older than 85 years are excluded.
Other
- Anyone who did not sign the Informed Consent form.
- Pregnant, parturient and nursing women are excluded
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| EFS GEST Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| EFS GEST Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.