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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02396355 |
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Date of registration:
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18/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Accuracy Evaluation of the BD FACS Presto System
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Scientific title:
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Accuracy Evaluation of the BD FACS Presto System: Instrument, Software and BD CD4/%CD4/Hb Cartridge Assay |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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583 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02396355 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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India
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Kenya
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Thailand
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United States
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Contacts
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Name:
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Kevin Judge, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Becton, Dickinson |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject has been infected with HIV and willing to provide informed consent to draw
venous and capillary blood
- Specimen: Venous blood must be collected in blood collection tube with EDTA
anticoagulant and stored at room temperature (20-25 °C) according to tube
manufacturer's instructions
- Specimen: post enrolment staining within 24 hours
- venous blood of acceptable quality for flow cytometry, e.g. no hemolysis or clots and
acceptable pre analytical handling)
- venous blood sample > 1 mL for sample preparation
- capillary blood applied to the investigational CD4/%CD4/Hb cartridge
Exclusion Criteria:
- Subject unwilling to disclose medical information regarding previous CD4 test results
- Subject unwilling to discuss medical information regarding co-morbid conditions and
current medications
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acquired Immunodeficiency Syndrome
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Intervention(s)
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Device: BD FACSCalibur flow cytometer
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Device: Sysmex hematology analyzer KX-21
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Device: Investigational BD FACSPresto System
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Primary Outcome(s)
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Method bias between BD FACSPresto System vs. Predicate in venous blood (AbsCD4 and %CD4)
[Time Frame: assayed upon sample collection]
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Secondary Outcome(s)
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Method bias between BD FACSPresto System vs. Predicate in Capillary Blood (AbsCD4 and %CD4)
[Time Frame: assayed upon sample collection]
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Method bias between BD FACSPresto System vs. Predicate for Hemoglobin
[Time Frame: assayed upon sample collection]
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Secondary ID(s)
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CAS-PCACC1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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