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NCT number NCT03495570
Study type Observational
Source University College, London
Contact Sarah L Pett, MD/PhD
Phone +44 (0)798 380 6215
Email s.pett@ucl.ac.uk
Status Not yet recruiting
Phase
Start date April 15, 2018
Completion date October 15, 2018

Clinical Trial Summary

The XN-20, is a full blood count (FBC) analyser with an extended differential counting and flagging System. The XN-Series' individual channels allow real-time reflex analysis, and uses a two stage process to classify the white blood count (WBC) sub-populations and detect the presence of abnormal reactive and malignant cells. In regards to lymphocytes in the peripheral blood, the machine has the capacity to distinguish activated from non-activated T-cell subsets using a very small volume of EDTA sample (88uL) (including remnant sample from a standard full blood count) with results available in 1.5 minutes. It is a fully automated process and can be considered as an alternative rapid flow cytometry method.

Objective of the SASA study: to investigate the signal pattern of white blood cells assessed using the XN-20 full blood count platform in patients with untreated viral infections i.e. HIV, HCV and HBV. The data from the analysis will be reviewed in conjunction with patient's demographic and clinical disease characteristics with the aim of detecting characteristic cell populations that can be used in the development of system flags for future studies.


Clinical Trial Description

Study design: observational pilot study. Approximately one hundred, participants (25 in each of group, A to D), will be enrolled at a single clinical site.

Study question: Do participants who have chronic or acute viral infections i.e. untreated HIV, HIV-HCV with treated HIV and untreated HCV, untreated HCV monoinfection or untreated HBV monoinfection, have a significant excess of activated lymphocytes as measured by D1+D2 on the XN WDF channel using the XN-20 analyser?

Objectives:

Primary: To assess whether participants who have chronic or acute viral infections have a significant excess of activated lymphocytes measured by the Sysmex-XN 20 analyser.

Secondary: To compare, the absolute numbers and percentages of lymphocytes subsets as measured in the Sysmex-XN 20 analyser to the percentages of these cells when measured using standard laboratory methods i.e. flow cytometry.

Primary Outcome Measure(s): Percentage of lymphocytes measured in area D1+D2 of the XN WDF and W1/W2 ratio from the WPC channel.

Secondary Outcome Measure(s ):

1. % lymphocytes in the D1 area of the XN WDF channel;

2. % lymphocytes in the D2 area of the XN WDF channel;

3. % lymphocytes in the D0 area of the XN WDF channel;

4. correlation between CD4+ T-cells (as measured by standard flow cytometry) and the D1+D2 area on the XN WDF channel;

5. correlation between CD8+ T-cells (as measured by standard flow cytometry) and the D1+D2 area on the XN WDF channel;

6. correlation between CD4+ T-cells (as measured by standard flow cytometry) and the W1/W2 area on the XN WPC channel;

7. correlation between CD8+ T-cells (as measured by standard flow cytometry) and the W1/W2 area on the XN WPC channel;

Exploratory:

Association of uncontrolled viral infection and the following as measured on the XN-20 platform

- % of lymphocytes mainly synthesizing antibodies with high fluorescence intensity (AS-Lymph);

- absolute and % lymphocytes reacting to infection with high fluorescence intensity (RE-Lymph);

- % reactive monocytes

- Neutrophil reactivity intensity;

- Neutrophil granularity intensity;

- Immature platelet fraction;

- Comparison of the blood film (DI-60 Review) and selected WBC subset read outs from the XN-20.

- Review of WDF lymphocyte cloud positional information using - HFLC/LY-X/LY-Y/LY-Z/LY-WX/LY-WY/LY-WZ.


Study Design


Related Conditions & MeSH terms


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