Hepatitis CNCT02992184
PoC-HCV Genedrive Viral Detection Assay Validation Study
An observational study of Hepatitis C, run by ANRS, Emerging Infectious Diseases.
Trial summary
The principal objective is to assess the diagnostic accuracy of the PoC assay (Genedrive, Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from patients with chronic hepatitis C and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- HCV RNA detection with Genedrive assay and HCV RNA detection with RealTime HCV
- Type of treatment
- Medical device
- How many people
- 417 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pre-treatment cohort: 228 HCV patients samples * Age > 18 years old. * Patients with positive HCV RNA. * Heparinized plasma samples are available before the initiation of antiviral HCV therapy. * Patients have given a written consent that their blood samples will be further used for research. Control samples : 189 controls * Age > 18 years old. * Participants were tested negative for anti-HCV antibody * Heparinized plasma samples are available * Participants have given a written consent that their blood samples will be further used for research
Who may be able to join
- Criteria for case
- Age > 18 years old.
- Patients with positive HCV RNA.
- Heparinized plasma samples are available before the initiation of antiviral HCV therapy.
- Patients have given a written consent that their blood samples will be further used for research.
- Criteria for control
Show all 10Show fewer
- Age > 18 years old.
- Participants were tested negative for anti-HCV antibody
- Heparinized plasma samples are available
- Participants have given a written consent that their blood samples will be further used for research
Who cannot join
- -
About this study
The principal objective is to assess the diagnostic accuracy of the PoC assay (Genedrive, Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from patients with chronic hepatitis C and non-infected controls.
- Conditions
- Hepatitis C
- Being tested
- HCV RNA detection with Genedrive assay, HCV RNA detection with RealTime HCV
- Keywords
- HCV, Genedrive, Point of Care
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCV RNA detection with Genedrive assayDevice
Also called HCV RNA detection with Point of Care assay
HCV RNA detection with RealTime HCVDevice
Also called HCV RNA detection with RT-PCR assay
| Study group | Role | What they receive |
|---|---|---|
| HCV patients | 228 HCV patients Receives: Device: HCV RNA detection with Genedrive assay; Device: HCV RNA detection with RealTime HCV | |
| control | 189 controls Receives: Device: HCV RNA detection with Genedrive assay; Device: HCV RNA detection with RealTime HCV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of HCV RNA detection with PoC assay (Genedrive, Epistem) vs reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott).
Assess the diagnostic accuracy of the PoC assay (Genedrive, Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from patients with chronic hepatitis C and non-infected controls (with Genedrive channel acceptance set at 2 out of 3).
Measured: pre-treatment
Secondary outcomes (3)
Diagnostic algorithm optimization
To optimize the diagnostic algorithm (i.e., 1, 2, or 3 out of 3 channels; repeat testing or not) that gives the optimal balance between sensitivity and specificity for detection of HCV RNA.
Measured: Pre-treatment
Factors associated with false-positive of false-negative results
To identify factors associated with false-positive or false-negative results of the PoC assay.
Measured: Pre-treatment
Assess the inter-examiner reproducibility of the PoC assay.
Measured: Pre-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- EPISTEM
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992184
- Sponsor's protocol ID
- ANRS HC POC VIRAL DETECTION
- Status last verified
- Dec 2016
- First submitted
- 12 Dec 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Llibre A, Shimakawa Y, Mottez E, Ainsworth S, Buivan TP, Firth R, Harrison E, Rosenberg AR, Meritet JF, Fontanet A, Castan P, Madejon A, Laverick M, Glass A, Viana R, Pol S, McClure CP, Irving WL, Miele G, Albert ML, Duffy D. Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus. Gut. 2018 Nov;67(11):2017-2024. doi: 10.1136/gutjnl-2017-315783. Epub 2018 Apr 3.
PubMed 29615488
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PoC-HCV Genedrive Viral Detection Assay Validation Study
- ClinicalTrials.gov ID
- NCT02992184
- Acronym / sponsor ID
- ANRS HC POC VIRAL DETECTION
- Conditions
- Hepatitis C
- Keywords
- HCV, Genedrive, Point of Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- EPISTEM
- Study start
- Sep 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Dec 2016 (estimated)
- 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 principal objective is to assess the diagnostic accuracy of the PoC assay (Genedrive, Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from patients with chronic hepatitis C and non-infected controls.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV patients | – | Device: HCV RNA detection with Genedrive assay, Device: HCV RNA detection with RealTime HCV228 HCV patients |
| control | – | Device: HCV RNA detection with Genedrive assay, Device: HCV RNA detection with RealTime HCV189 controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pre-treatment cohort: 228 HCV patients samples * Age > 18 years old. * Patients with positive HCV RNA. * Heparinized plasma samples are available before the initiation of antiviral HCV therapy. * Patients have given a written consent that their blood samples will be further used for research. Control samples : 189 controls * Age > 18 years old. * Participants were tested negative for anti-HCV antibody * Heparinized plasma samples are available * Participants have given a written consent that their blood samples will be further used for research
Key inclusion criteria (10 listed)
- Criteria for case
- Age > 18 years old.
- Patients with positive HCV RNA.
- Heparinized plasma samples are available before the initiation of antiviral HCV therapy.
- Patients have given a written consent that their blood samples will be further used for research.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| HCV RNA detection with Genedrive assayAlso: HCV RNA detection with Point of Care assay | Device | HCV patients, control |
| HCV RNA detection with RealTime HCVAlso: HCV RNA detection with RT-PCR assay | Device | HCV patients, control |
Primary outcome
Accuracy of HCV RNA detection with PoC assay (Genedrive, Epistem) vs reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott).
Time frame: pre-treatment
Assess the diagnostic accuracy of the PoC assay (Genedrive, Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from patients with chronic hepatitis C and non-infected controls (with Genedrive channel acceptance set at 2 out of 3).
3 secondary outcomes
Diagnostic algorithm optimization
Time frame: Pre-treatment
Factors associated with false-positive of false-negative results
Time frame: Pre-treatment
Assess the inter-examiner reproducibility of the PoC assay.
Time frame: Pre-treatment
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 14 Dec 2016.
- Derived from this study: PubMed 29615488Llibre A, Shimakawa Y, Mottez E, Ainsworth S, Buivan TP, Firth R, Harrison E, Rosenberg AR, Meritet JF, Fontanet A, Castan P, Madejon A, Laverick M, Glass A, Viana R, Pol S, McClure CP, Irving WL, Miele G, Albert ML, Duffy D. Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus. Gut. 2018 Nov;67(11):2017-2024. doi: 10.1136/gutjnl-2017-315783. Epub 2018 Apr 3.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by ANRS, Emerging Infectious Diseases.
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 10 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 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Accuracy of HCV RNA detection with PoC assay (Genedrive, Epistem) vs reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott). (time frame: pre-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02992184, which also lists 1 linked publication.
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 14 Dec 2016.