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PoC-HCV Genedrive Viral Detection Assay Validation Study

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ClinicalTrials.gov Identifier: NCT02992184
Recruitment Status : Completed
First Posted : December 14, 2016
Last Update Posted : December 14, 2016
Sponsor:
Collaborator:
EPISTEM
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Tracking Information
First Submitted Date December 12, 2016
First Posted Date December 14, 2016
Last Update Posted Date December 14, 2016
Study Start Date September 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 13, 2016)
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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 13, 2016)
  • Diagnostic algorithm optimization [ Time Frame: Pre-treatment ]
    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.
  • Factors associated with false-positive of false-negative results [ Time Frame: Pre-treatment ]
    To identify factors associated with false-positive or false-negative results of the PoC assay.
  • Assess the inter-examiner reproducibility of the PoC assay. [ Time Frame: Pre-treatment ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PoC-HCV Genedrive Viral Detection Assay Validation Study
Official Title Not Provided
Brief 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 non-infected controls.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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
Condition Hepatitis C
Intervention
  • Device: HCV RNA detection with Genedrive assay
    Other Name: HCV RNA detection with Point of Care assay
  • Device: HCV RNA detection with RealTime HCV
    Other Name: HCV RNA detection with RT-PCR assay
Study Groups/Cohorts
  • HCV patients
    228 HCV patients
    Interventions:
    • Device: HCV RNA detection with Genedrive assay
    • Device: HCV RNA detection with RealTime HCV
  • control
    189 controls
    Interventions:
    • Device: HCV RNA detection with Genedrive assay
    • Device: HCV RNA detection with RealTime HCV
Publications * Llibre A, Shimakawa Y, Mottez E, Ainsworth S, Buivan TP, Firth R, Harrison E, Rosenberg AR, Meritet JF, Fontanet A, Castan P, Madejón 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 13, 2016)
417
Original Actual Enrollment Same as current
Actual Study Completion Date December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

  • 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

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02992184
Other Study ID Numbers ANRS HC POC VIRAL DETECTION
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ANRS, Emerging Infectious Diseases
Study Sponsor ANRS, Emerging Infectious Diseases
Collaborators EPISTEM
Investigators Not Provided
PRS Account ANRS, Emerging Infectious Diseases
Verification Date December 2016