- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03896087
Evaluation of Dried Blood Spot for HCV RNA Testing
Multicentre Clinical Trial to Assess the Performance of Centralized Assays for Hepatitis C Virus RNA Detection From Dried Blood Spot (DBS) Samples
Study Overview
Status
Conditions
Detailed Description
Available data on the performance of HCV RNA assays from DBS samples are insufficient to introduce their use in clinical practice. Only a few studies have been performed on DBS stored at ambient temperature, while the majority had DBS samples refrigerated or frozen right after collection, which does not mimic real-life settings. Additionally, due to the lack of standardized procedures, DBS collection and elution protocols varied across different studies. A large multicentre diagnostic accuracy study using standardized DBS collection and elution protocols validated by test manufacturers is needed to inform national hepatitis programmes and international guideline development groups. Test manufacturers need clinical evaluation data to update their regulatory claims and include DBS as an alternative sample type.
FIND is preparing a trial to evaluate the performance, as measured by sensitivity and specificity, of four laboratory-based assays for detection of HCV RNA assays using capillary blood collected on DBS/PSC. This will be provisional on the manufacturers agreeing to participate, as well as committing to applying to stringent regulatory approval for DBS/PSC.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Fitzroy
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Victoria Park, Fitzroy, Australia, 3065
- St Vincent's Institute of Medical Research National Serology Reference Laboratory
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Yaounde
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Yaoundé, Yaounde, Cameroon
- Centre Pasteur du Cameroun
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Tbilisi, Georgia
- National Centre for Disease Control
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Athens, Greece, 11527
- Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases
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Kanombe
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Kigali, Kanombe, Rwanda, 0000
- Rwanda Military Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Three different population groups will be considered:
Individuals at risk of having HCV infection based on positive HCV serology test results
Inclusion criteria:
- Aged 18 years or older
- Able to understand the scope of the trial
- Provided written informed consent
- Documented positive result of HCV serology test
Individuals at risk of having HCV infection based on past and/or current exposure to risk factors
Inclusion criteria:
- Aged 18 years or older
- Able to understand the scope of the trial
- Provided written informed consent
- Past and/or current exposure to one of the high risk factors as defined by WHO and CDC guidelines (Appendix I)
- Individuals diagnosed with chronic HCV infection who initiated or completed the anti-HCV treatment with direct acting antivirals (DAA) presenting at the clinical site for treatment monitoring or test of cure (i.e. sustained virological response)
Inclusion criteria:
- Aged 18 years or older
- Able to understand the scope of the trial
- Provided written informed consent
- Initiated on DAA treatment (regardless of type of DAA regimen) within 12 months prior to the enrolment to the trial
Exclusion criteria (for all trial populations):
- Previously enrolled in the trial
- Unwilling to provide required volume of fingerstick blood
- Unwilling to provide required volume of venous whole blood
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: clinical performance of the HCV DBS assay
The study will be conducted in different geographical regions and populations and is designed to meet requirements of the for assays (medical devices) used for the qualitative and quantitative detection of Hepatitis C RNA.
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The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays for detection of HCV RNA.
Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 6800/8800 Systems for detection of HCV RNA.
Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays Aptima® HCV Quant Dx Assay from DBS for detection of HCV RNA.
Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 4800 for detection of HCV RNA.
Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
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Active Comparator: comparison PQ marked reference assay arm
Plasma specimens from the participants will be tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities.
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The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays for detection of HCV RNA.
Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 6800/8800 Systems for detection of HCV RNA.
Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays Aptima® HCV Quant Dx Assay from DBS for detection of HCV RNA.
Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 4800 for detection of HCV RNA.
Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against Abbott RealTime HCV VL assay performed at the clinical site
Time Frame: day 1 - day 30
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Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against Abbott RealTime HCV VL assay performed at the clinical site
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day 1 - day 30
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Evaluation of the correlation of HCV viral load level determined by each assay performed from DBS and/or PSC specimens with the HCV viral load level in plasma determined by Abbott RealTime HCV VL assay performed at the clinical site
Time Frame: day 1 - day 30
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Evaluation of the correlation of HCV viral load level determined by each assay performed
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day 1 - day 30
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against the performance of the same assay in plasma
Time Frame: day 1 - day 30
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Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against the performance of the same assay in plasma
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day 1 - day 30
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Evaluation of the correlation of HCV viral load level determined by each assay performed from DBS and/or PSC specimens with the HCV RNA level in plasma determined by the same assay
Time Frame: day 1 - day 30
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Evaluation of the correlation of HCV viral load level determined by each assay performed from DBS and/or PSC specimens with the HCV RNA level in plasma determined by the same assay
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day 1 - day 30
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WHO technician's appraisal sheet completed by all operators performing investigational test
Time Frame: through study completion, an average of 1 year
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WHO technician's appraisal sheet completed by all operators performing investigational test
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through study completion, an average of 1 year
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point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection in plasma measured against the performance of Roche cobas® 6800 HCV VL assay
Time Frame: day 7 - day 30
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For Central Laboratory only
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day 7 - day 30
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evaluation of the correlation of HCV RNA levels in plasma determined by each assay with HCV RNA levels in plasma determined by Roche cobas® 6800 HCV VL assay
Time Frame: day 7 - day 30
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For Central Laboratory only
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day 7 - day 30
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Elena Ivanova, Ph.D., Foundation for Innovative New Diagnostics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8160-2/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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