HIV I InfectionHIV-EU-11-18NCT04971343
Access HIV Ag/Ab Combo Assay - European Union (EU) Clinical Trial Protocol
An observational study of HIV I Infection and HIV-2 Infection, run by Beckman Coulter, Inc. at 6 sites in France.
Trial summary
The objective of this study is the collection and testing of clinical samples to determine the clinical performance of the Access HIV Ag/Ab Combo assay on the DxI 9000 Access Immunoassay Analyzer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV I Infection, HIV-2 Infection
- What is being tested?
- Access HIV_blood donor, Access HIV_Hospitalized patient and Access HIV_known HIV-1 antibody positives
- How many people
- 8,650 participants
- Where
- 6 sitesFrance
- Study dates
- 4 Dec 2019to 23 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The test population includes : * 6,000 unselected blood donors sample * 2,000 hospitalized patients * 500 Known HIV-1 Ab positive * 100 Known HIV-2 Ab positive * 50 Known acute HIV-1 p24 Ag positive
Who may be able to join
- Anonymized or pseudo-anonymized leftover samples from
- Males or females
- Aged ≥18 years of age
- Belonging to one of the following enrollment groups:
- Unselected blood donor
- Hospitalized patient
Show all 20Show fewer
- Known HIV-1 antibody positive patients
- confirmed positive by Immunoblot, Western blot or HIV-1/HIV-2 antibody differentiation test either at time of enrollment vai same study draw or historically from medical record
- Known HIV-2 antibody positive patients
- confirmed HIV-2 positive by BioPlex 2200 HIV Ag-Ab Assay
- Known HIV-1 Ag positive patients
- For samples from HIV seroconversion panels
- Tested during EU HIV clinical trial: confirmed positive by screening HIV Ag/Ab combo positive for p24 Ag, and p24 Ag screening test positive (result from CoA or additional testing)
- Tested as part of seroconversion panel studies (V\&V studies): First sample of the panel that is ARCHITECT Ag/Ab combo assay positive or BioPlex 2200 HIV Ag-Ab Assay p24 positive, and p24 Ag test positive (result from CoA or additional R\&D testing)
- For routine clinical samples:
- Confirmed positive by screening HIV Ag/Ab combo assay positive for p24 Ag , and p24 Ag test positive by confirmatory test, or
- Confirmed positive by screening HIV Ag/Ab combo assay HIV positive, and p24 Ag test positive by confirmatory test and PCR HIV POS and IB/WB HIV negative or indetermined.
- with at least 2.0 mL leftover EDTA plasma sample from hospitalized patients OR
- at least 1.5 mL leftover EDTA plasma or serum sample from blood donors or known HIV-1 antibody positive patients, with confirmatory test already done as per inclusion criteria OR
- at least 1.0 mL leftover EDTA plasma or serum sample from known p24 Ag positive patients or known HIV-2 antibody positive patients, with confirmatory test already done as per inclusion criteria
Who cannot join
- Samples from subjects already included in the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Etablissement Français du Sang (EFS) Hauts-de-France - Normandie
Bois-Guillaume, 76232
Eurofins Biomnis
Ivry-sur-Seine, 94208
Qbd, Efs Hfno
Loos, 59120
UPR Lille, Établissement français du sang Hauts-de-France - Normandie
Loos, 59373
Laboratoire de Virologie, Laboratoire associé au CNR du VIH
Rouen, 76031
Cerba Xpert
Saint-Ouen-l'Aumône, 95310
About this study
Official title: Evaluation of the Beckman Coulter Access HIV Ag/Ab Combo Assay as an Aid in the Diagnosis of HIV-1 and/or HIV-2 Infection: EU Clinical Trial Protocol
The objective of this study is the collection and testing of clinical samples to determine the clinical performance of the Access HIV Ag/Ab Combo assay on the DxI 9000 Access Immunoassay Analyzer
Read the detailed description
The study will involve a multicenter, prospective and retrospective sample collection, and testing of samples with the investigational HIV assay as required per the EU Common Technical Specification (CTS). The CTS requires testing of samples from blood donors, hospitalized patients, known HIV-1 Ab positive patients, known HIV-2 Ab positive patients, and known HIV-1 p24 Ag positive patients. Any retrospectively collected samples will meet all inclusion/exclusion criteria.
All samples collected will be anonymized or pseudo-anonymized, leftover, remnant samples. pseudo-anonymized collection of samples will required oral patient consent documented in their medical record or electronic case report form (eCRF). For CE marking, below is the number of samples that will be included per group :
- Unselected blood donors : 6,000 fresh samples (requirements CTS : 5,000)
- Hospitalized patients : 1,200 frozen samples and 800 fresh samples (requirements CTS : 200)
- Known HIV-1 Ab positive : 470 frozen samples and 30 fresh samples (requirements CTS : 400)
- Known HIV-2 Ab positive : 100 frozen samples (requirements CTS : 100)
- Known acute HIV-1 p24 Ag positive : 50 frozen samples (requirements CTS : 50)
The following additional design requirements will be incorporated to EU study to satisfy Canadian regulations, but additional data generated on the additional samples will not be used for CE-marking:
- Collection and testing of 4,000 additional blood donor samples. Blood donors' samples should include 300 blood donor matched fresh plasma and serum samples
- Distribution of blood donor sample testing equally over three (3) blood donor sites, using 3 different lots of reagents
- Retesting of 1000 blood donor samples internally with 1 lot close to expiration
- Collection and testing of maximum 210 additional p24 Ag positive sample beyond the 50 required by CTS
- Distribution of p24 Ag and HIV-1 Ab positive sample testing equally over three (3) testing sites, using 3 different lots of reagents.
Additional Canadian requirements will be covered by US protocol(s) and Verification and validation protocols.
- Conditions
- HIV I Infection, HIV-2 Infection
- Being tested
- Access HIV_blood donor, Access HIV_Hospitalized patient, Access HIV_known HIV-1 antibody positives, Access HIV_known HIV-2 antibody positives, Access HIV_known HIV-1 p24 Ag positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access HIV_blood donorDiagnostic test
Samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Roche - Cobas - Elecsys® HIV Duo .
- All initially reactive specimen results will be tested in duplicate per IFU .
- All RR specimens will be confirmed using testing including ImmunoBlot, Western Blot or HIV-1/HIV-2 differentiation test and HIV-1 PCR, RNA (if Immunoblot, WesternBlot or differentiation test is negative or indeterminate; if Immunoblot, WesternBlot or differentiation test is positive for HIV-2 then HIV-1 PCR will not be tested).
Access HIV_Hospitalized patientDiagnostic test
All samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay for hospitalized patient.
- All initially reactive specimen results will be tested in duplicate per IFU .
- All RR specimens will be confirmed using testing including ImmunoBlot, Western Blot or HIV-1/HIV-2 differentiation test and HIV-1 PCR, RNA (if Immunoblot, WesternBlot or differentiation test is negative or indeterminate; if Immunoblot, WesternBlot or differentiation test is positive for HIV-2 then HIV-1 PCR will not be tested).
Access HIV_known HIV-1 antibody positivesDiagnostic test
Samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay .
- All initially reactive specimen results will be tested in duplicate per IFU .
- For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays.
In case of discrepant results or concordant negative results between Access and Reference HIV Ag/Ab combo assay among known HIV-1 antibody positive patients, the IB/WB test will be repeated by the site to confirm sample status. If this IB/WB result is negative or indeterminate, the sample will be excluded from the statistical analysis
Access HIV_known HIV-2 antibody positivesDiagnostic test
Samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay.
- All initially reactive specimen results will be tested in duplicate per IFU .
- For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays.
Access HIV_known HIV-1 p24 Ag positiveDiagnostic test
All samples will be tested with both Reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFUs/study guide to determine non-reactive (NR), initially reactive (IR), and repeatedly reactive (RR). Reference assay will be Abbott - ARCHITECT HIV Ag/Ab Combo Assay.
- Due to volume constraints, all known HIV-1 p24 Ag positive samples that will be tested during the EU HIV clinical trial will be tested in singulare only with the Reference HIV Ag/Ab combo assay, and in singulare and then in duplicate if IR with Access HIV Ag/Ab combo assay.
- For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays
Access HIV_Canada's requirements_Blood donorDiagnostic test
To fit with Canada's requirements:
- 4,000 additional blood donor samples from geographically distinct regions will be collected and tested. Blood donor sample testing will be equally distributed over three blood donor sites, using 3 different lots of reagents: the first 2,000 blood donor samples from CE-marking study (out of the 6,000 tested) will be used plus the 4,000 additional blood donor samples.
- Retesting of 1000 blood donor samples will be done internally with 1 lot close to expiration to satisfy Canadian requirements
Access HIV_Canada's requirements_HIV positiveDiagnostic test
To fit with Canada's requirements:
- HIV positive samples will be equally distributed and tested at leat three (3) testing sites, using 3 lots of reagents.
Access HIV_Canada's requirements_P24 PositiveDiagnostic test
To fit with Canada's requirements:
- HIV positive samples will be equally distributed and tested at leat three (3) testing sites, using 3 lots of reagents.
- Collection and testing of maximum 210 additional HIV-1 Ag positive sample beyond the 50 required by CTS
| Study group | Role | What they receive |
|---|---|---|
| Unselected blood donors | Not described Receives: Diagnostic Test: Access HIV_blood donor; Diagnostic Test: Access HIV_Canada's requirements_Blood donor | |
| Hospitalized patients | Not described Receives: Diagnostic Test: Access HIV_Hospitalized patient | |
| Known HIV-1 Ab positive | Not described Receives: Diagnostic Test: Access HIV_known HIV-1 antibody positives; Diagnostic Test: Access HIV_Canada's requirements_HIV positive | |
| Known HIV-2 Ab positive | Not described Receives: Diagnostic Test: Access HIV_known HIV-2 antibody positives; Diagnostic Test: Access HIV_Canada's requirements_HIV positive | |
| Known Acute HIV-1 p24 Ag positive | Not described Receives: Diagnostic Test: Access HIV_known HIV-1 p24 Ag positive; Diagnostic Test: Access HIV_Canada's requirements_HIV positive; Diagnostic Test: Access HIV_Canada's requirements_P24 Positive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity
Sensitivity and specificity relative to the final patient HIV infection status determined from confirmatory testing will be calculated.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start4 Dec 2019
- Primary completion22 Jun 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV I InfectionStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 8,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971343
- Sponsor's protocol ID
- DC-TR18-0410
- Acronym
- HIV-EU-11-18
- Status last verified
- Mar 2025
- First submitted
- 12 Jul 2021
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Beckman Coulter Access HIV Ag/Ab Combo Assay as an Aid in the Diagnosis of HIV-1 and/or HIV-2 Infection: EU Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT04971343
- Acronym / sponsor ID
- HIV-EU-11-18 / DC-TR18-0410
- Conditions
- HIV I Infection, HIV-2 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,650 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 21 Jul 2021 (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.
The objective of this study is the collection and testing of clinical samples to determine the clinical performance of the Access HIV Ag/Ab Combo assay on the DxI 9000 Access Immunoassay Analyzer
Detailed description
The study will involve a multicenter, prospective and retrospective sample collection, and testing of samples with the investigational HIV assay as required per the EU Common Technical Specification (CTS). The CTS requires testing of samples from blood donors, hospitalized patients, known HIV-1 Ab positive patients, known HIV-2 Ab positive patients, and known HIV-1 p24 Ag positive patients. Any retrospectively collected samples will meet all inclusion/exclusion criteria.
All samples collected will be anonymized or pseudo-anonymized, leftover, remnant samples. pseudo-anonymized collection of samples will required oral patient consent documented in their medical record or electronic case report form (eCRF). For CE marking, below is the number of samples that will be included per group :
- Unselected blood donors : 6,000 fresh samples (requirements CTS : 5,000)
- Hospitalized patients : 1,200 frozen samples and 800 fresh samples (requirements CTS : 200)
- Known HIV-1 Ab positive : 470 frozen samples and 30 fresh samples (requirements CTS : 400)
- Known HIV-2 Ab positive : 100 frozen samples (requirements CTS : 100)
- Known acute HIV-1 p24 Ag positive : 50 frozen samples (requirements CTS : 50)
The following additional design requirements will be incorporated to EU study to satisfy Canadian regulations, but additional data generated on the additional samples will not be used for CE-marking:
- Collection and testing of 4,000 additional blood donor samples. Blood donors' samples should include 300 blood donor matched fresh plasma and serum samples
- Distribution of blood donor sample testing equally over three (3) blood donor sites, using 3 different lots of reagents
- Retesting of 1000 blood donor samples internally with 1 lot close to expiration
- Collection and testing of maximum 210 additional p24 Ag positive sample beyond the 50 required by CTS
- Distribution of p24 Ag and HIV-1 Ab positive sample testing equally over three (3) testing sites, using 3 different lots of reagents.
Additional Canadian requirements will be covered by US protocol(s) and Verification and validation protocols.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Unselected blood donors | – | Diagnostic Test: Access HIV_blood donor, Diagnostic Test: Access HIV_Canada's requirements_Blood donor |
| Hospitalized patients | – | Diagnostic Test: Access HIV_Hospitalized patient |
| Known HIV-1 Ab positive | – | Diagnostic Test: Access HIV_known HIV-1 antibody positives, Diagnostic Test: Access HIV_Canada's requirements_HIV positive |
| Known HIV-2 Ab positive | – | Diagnostic Test: Access HIV_known HIV-2 antibody positives, Diagnostic Test: Access HIV_Canada's requirements_HIV positive |
| Known Acute HIV-1 p24 Ag positive | – | Diagnostic Test: Access HIV_known HIV-1 p24 Ag positive, Diagnostic Test: Access HIV_Canada's requirements_HIV positive, Diagnostic Test: Access HIV_Canada's requirements_P24 Positive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The test population includes : * 6,000 unselected blood donors sample * 2,000 hospitalized patients * 500 Known HIV-1 Ab positive * 100 Known HIV-2 Ab positive * 50 Known acute HIV-1 p24 Ag positive
Key inclusion criteria (20 listed)
- Anonymized or pseudo-anonymized leftover samples from
- Males or females
- Aged ≥18 years of age
- Belonging to one of the following enrollment groups:
- with at least 2.0 mL leftover EDTA plasma sample from hospitalized patients OR
Key exclusion criteria (1 listed)
- Samples from subjects already included in the study
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 |
|---|---|---|
| Access HIV_blood donorSamples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Roche - Cobas - Elecsys® HIV Duo . * All initially reactive specimen results will be tested in duplicate per IFU . * All RR specimens will be confirmed using testing including ImmunoBlot, Western Blot or HIV-1/HIV-2 differentiation test and HIV-1 PCR, RNA (if Immunoblot, WesternBlot or differentiation test is negative or indeterminate; if Immunoblot, WesternBlot or differentiation test is positive for HIV-2 then HIV-1 PCR will not be tested). | Diagnostic test | Unselected blood donors |
| Access HIV_Hospitalized patientAll samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay for hospitalized patient. * All initially reactive specimen results will be tested in duplicate per IFU . * All RR specimens will be confirmed using testing including ImmunoBlot, Western Blot or HIV-1/HIV-2 differentiation test and HIV-1 PCR, RNA (if Immunoblot, WesternBlot or differentiation test is negative or indeterminate; if Immunoblot, WesternBlot or differentiation test is positive for HIV-2 then HIV-1 PCR will not be tested). | Diagnostic test | Hospitalized patients |
| Access HIV_known HIV-1 antibody positivesSamples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay . * All initially reactive specimen results will be tested in duplicate per IFU . * For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays. In case of discrepant results or concordant negative results between Access and Reference HIV Ag/Ab combo assay among known HIV-1 antibody positive patients, the IB/WB test will be repeated by the site to confirm sample status. If this IB/WB result is negative or indeterminate, the sample will be excluded from the statistical analysis | Diagnostic test | Known HIV-1 Ab positive |
| Access HIV_known HIV-2 antibody positivesSamples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay. * All initially reactive specimen results will be tested in duplicate per IFU . * For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays. | Diagnostic test | Known HIV-2 Ab positive |
| Access HIV_known HIV-1 p24 Ag positiveAll samples will be tested with both Reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFUs/study guide to determine non-reactive (NR), initially reactive (IR), and repeatedly reactive (RR). Reference assay will be Abbott - ARCHITECT HIV Ag/Ab Combo Assay. * Due to volume constraints, all known HIV-1 p24 Ag positive samples that will be tested during the EU HIV clinical trial will be tested in singulare only with the Reference HIV Ag/Ab combo assay, and in singulare and then in duplicate if IR with Access HIV Ag/Ab combo assay. * For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays | Diagnostic test | Known Acute HIV-1 p24 Ag positive |
| Access HIV_Canada's requirements_Blood donorTo fit with Canada's requirements: * 4,000 additional blood donor samples from geographically distinct regions will be collected and tested. Blood donor sample testing will be equally distributed over three blood donor sites, using 3 different lots of reagents: the first 2,000 blood donor samples from CE-marking study (out of the 6,000 tested) will be used plus the 4,000 additional blood donor samples. * Retesting of 1000 blood donor samples will be done internally with 1 lot close to expiration to satisfy Canadian requirements | Diagnostic test | Unselected blood donors |
| Access HIV_Canada's requirements_HIV positiveTo fit with Canada's requirements: o HIV positive samples will be equally distributed and tested at leat three (3) testing sites, using 3 lots of reagents. | Diagnostic test | Known Acute HIV-1 p24 Ag positive, Known HIV-1 Ab positive, Known HIV-2 Ab positive |
| Access HIV_Canada's requirements_P24 PositiveTo fit with Canada's requirements: * HIV positive samples will be equally distributed and tested at leat three (3) testing sites, using 3 lots of reagents. * Collection and testing of maximum 210 additional HIV-1 Ag positive sample beyond the 50 required by CTS | Diagnostic test | Known Acute HIV-1 p24 Ag positive |
Primary outcome
Sensitivity and specificity
Time frame: Baseline
Sensitivity and specificity relative to the final patient HIV infection status determined from confirmatory testing will be calculated.
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 19 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV I Infection and HIV-2 Infection, run by Beckman Coulter, Inc. at 6 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 20 inclusion and 1 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 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Sensitivity and specificity (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 19 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.