Genetic Health RisksApoDiagNCT06432192
A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis
An observational study of Genetic Health Risks, run by Firalis SA at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Genetic Health Risks
- What is being tested?
- APO-Easy
- How many people
- 1,474 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Jan 2024to 25 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy donors
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Genetic Health Risks
- Being tested
- APO-Easy
- Keywords
- Polygenic risk, APOE, Apolipoprotein, Neurodegenerative disorders, Dementia, Alzheimer disease, Genetic risks
- Medical subject headings
- Neurodegenerative Diseases, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APO-EasyDiagnostic test
Testing for the APOE genotype using the APO-Easy Genotyping test
| Study group | Role | What they receive |
|---|---|---|
| APOE E | The cohort will be genotyped to determine the phenotype of the APOE allele Receives: Diagnostic Test: APO-Easy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (1)
Specimen stability
Blood samples will be collected to establish the stability of PAXgene DNA samples at different timepoints after storage at -20° and -80°C.
Measured: Baseline, 24hrs, 5 days, 28 days, 3 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start2 Jan 2024
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic Health RisksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firalis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huseyin Firat, MD PhD, Study director, Firalis SALucas Pham-Van, PhD, Study chair, Firalis SAJoanna Michel, Study chair, Firalis SASthepanie Boutillier, PhD, Study director, Firalis SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432192
- Sponsor's protocol ID
- 2023-A02120-45
- Acronym
- ApoDiag
- Status last verified
- Sep 2024
- First submitted
- 22 May 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ApoDiag: A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis
- ClinicalTrials.gov ID
- NCT06432192
- Acronym / sponsor ID
- ApoDiag / 2023-A02120-45
- Conditions
- Genetic Health Risks
- Keywords
- Polygenic risk, APOE, Apolipoprotein, Neurodegenerative disorders, Dementia, Alzheimer disease, Genetic risks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,474 participants (actual)
- Lead sponsor
- Firalis SAIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APOE E | – | Diagnostic Test: APO-EasyThe cohort will be genotyped to determine the phenotype of the APOE allele |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy donors
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APO-EasyTesting for the APOE genotype using the APO-Easy Genotyping test | Diagnostic test | APOE E |
Primary outcome
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
1 secondary outcome
Specimen stability
Time frame: Baseline, 24hrs, 5 days, 28 days, 3 months, 12 months, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huseyin Firat, MD PhD study director
Firalis SA
Lucas Pham-Van, PhD study chair
Firalis SA
Joanna Michel study chair
Firalis SA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Health Risks, run by Firalis SA at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
APOE Genotype (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.