Qualification of Point-of-Care Assays for Management of HCV Patients (ANRS HC POC)
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|ClinicalTrials.gov Identifier: NCT02335320|
Recruitment Status : Unknown
Verified March 2015 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).
Recruitment status was: Recruiting
First Posted : January 9, 2015
Last Update Posted : March 23, 2015
Acute or chronic HCV infection can lead to liver complications, including liver failure, cirrhosis or liver cancer. For patients with hepatitis C infection, the major clinical question remains the terms of treatment initiation. In Europe, new treatments are available since the approval of three direct acting antivirals. However with the high cost of these treatments, they are currently only available for critically ill patients. Other molecules are currently in advanced clinical development phases. The use of clinical predictors remains relevant for the selection of a suitable treatment for each patient, in particular to limit the adverse effects and reduce costs. Currently the quantification of viral load is a measure of response to treatment; with the recommendation to stop treatment in patients who fail to achieve an undetectable level of viral load. Genetic factors have also been identified as predictors of response to treatment, in particular polymorphisms of the IL-28B gene. Genotyping of this gene is currently performed using classical PCR amplification applied to DNA extracted from blood, with a time to result of 2-3 weeks. We propose in this protocol to test a non-invasive method and rapid test for IL-28B genotype which could be used for point of caring testing, and ultimately better patient management.
This is a monocenter, cross-sectional study among HCV chronic patients. The study will be conducted in 250 HCV patients, all viral genotypes combined, at Cochin Hospital (Paris, France).
Objectives The principal objective is to assess the accuracy of the newly developed Point-of-Care genotyping assay (Genedrive® IL-28B Assay) to detect in HCV patients the genotype CC versus non CC (i.e. CT and TT) against the TaqMan Allelic Discrimination Assay as gold standard.
The secondary objective is to assess the concordance between the genotype results of the Genedrive and the gold standard regarding the three genotypes CC, CT and TT.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Qualification of Point-of-Care Assays for Management of HCV Patients|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2016|
- proportion of patients with genotype IL-28B C/C versus IL-28B non C/C patients [ Time Frame: D1 ]The study is based on the comparison of the genotyping results for SNP rs1297860 (IL-28B gene) between the Genedrive® assay and the gold standard assay.
- proportion of patients of whom the genotype results are identical between the index test and the gold standard test. [ Time Frame: D1 ]For secondary endpoints the three genotypes (C/C, C/T, T/T) are considered
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335320
|Contact: Stanislas Pol, Professor||1 58 41 30 01 ext +email@example.com|
|Groupe Hospitalier Cochin Saint-Vincent de Paul||Recruiting|
|Paris, France, 75679|
|Contact: Stanislas Pol, Professor 1 58 41 30 01 ext +33 firstname.lastname@example.org|