Sysmex-XN 20 Analyser to Assess Lymphocyte Subsets and Other Haematological Parameters in Chronic/Acute Viral Infections
SASA
An Observational Study Exploring the Utility of the Sysmex-XN 20 Analyser to Assess Lymphocyte Subsets and Other Haematological Parameters in Chronic or Acute Viral Infections,
1 other identifier
observational
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2018
CompletedFirst Posted
Study publicly available on registry
April 12, 2018
CompletedStudy Start
First participant enrolled
April 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2018
CompletedApril 12, 2018
March 1, 2018
4 months
March 21, 2018
April 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of lymphocytes measured in area D1+D2 of the XN WDF and W1/W2 ratio from the WPC channel.
Day 1
Secondary Outcomes (6)
% lymphocytes in the D1 and D2 area of the XN WDF channel
Day 1
% lymphocytes in the D0 area of the XN WDF channel;
Day 1
correlation between CD4+ T-cells (as measured by standard flow cytometry) and the D1+D2 area on the XN WDF channel;
Day 1
correlation between CD8+ T-cells (as measured by standard flow cytometry) and the D1+D2 area on the XN WDF channel;
Day 1
correlation between CD4+ T-cells (as measured by standard flow cytometry) and the W1/W2 area on the XN WPC channel;
Day 1
- +1 more secondary outcomes
Study Arms (4)
A
HIV-infected (chronic or acute infection) with a HIV viral load of \>1000 copies/mL in the 6 months prior to study entry and not (yet) in receipt of combination antiretroviral therapy (cART) at study entry.
B
HIV-infected on cART with HIV viral load \<50 copies/mL within the 6 months prior to study entry, at least one measure of HCV (chronic or acute infection) showing a detectable HCV viral load and not in receipt of HCV treatment at study entry.
C
HCV mono-infected (chronic or acute infection) with detectable HCV viral load (\>lower limit of quantification) in the prior 6 months and not in receipt of HCV treatment at study entry.
D
HBV mono-infected (chronic or acute infection) patients with detectable HBV viral load in the prior 6 months and not in receipt of HBV treatment at study entry.
Interventions
single one time blood draw to measure lymphocyte panels included activated lymphocytes using remnant sample from a full blood count
Eligibility Criteria
Four groups of participants with chronic or acute viral infections :1) Group A: untreated Human Immunodeficiency Virus (HIV)-infected; 2) Group B: HIV-hepatitis C (HIV/HCV) coinfected, with treated HIV but untreated HCV; 3) Group C: untreated HCV monoinfection; 4) Group D: untreated Hepatitis B (HBV) monoinfection.
You may qualify if:
- Adults aged ≥18 years;
- Registered patient at Mortimer Market Centre;
- Willing to have a blood draw for the purpose of the study or, if the participant is having a blood draw for routine care, willing to have an additional EDTA sample taken at the time of that routine blood draw and willing that the results of the sample being drawn for standard care (FBC and T-cell subsets) can be used for this study;
- In one of the four mutually exclusive groups:
- i) Group A: HIV-infected (chronic or acute infection) with a HIV viral load of \>1000 copies/mL in the 6 months prior to study entry and not (yet) in receipt of combination antiretroviral therapy (cART) at study entry; ii) Group B: HIV-infected on cART with HIV viral load \<50 copies/mL within the 6 months prior to study entry, at least one measure of HCV (chronic or acute infection) showing a detectable HCV viral load and not in receipt of HCV treatment at study entry; iii) Group C: HCV mono-infected (chronic or acute infection) with detectable HCV viral load (\>lower limit of quantification) in the prior 6 months and not in receipt of HCV treatment at study entry; iv) Group D: HBV mono-infected (chronic or acute infection) patients with detectable HBV viral load in the prior 6 months and not in receipt of HBV treatment at study entry.
- \- written informed consent.
You may not qualify if:
- On immunosuppressants and/or receiving chemotherapy or radiotherapy for a malignancy;
- Intercurrent infection within the prior 30 days (e.g. influenza like illness).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mortimer Market centre
London, WC1E 6JB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sarah L Pett, MD/PhD
University College, London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2018
First Posted
April 12, 2018
Study Start
April 15, 2018
Primary Completion
August 15, 2018
Study Completion
October 15, 2018
Last Updated
April 12, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share
We aim to recruit 100 participants in total, which will give us twenty-five participants per group. This is a convenience sample size that considered reasonable for this pilot, and can be recruited in the time frame allowed for this study, approximately 6 months. A simple descriptive analysis of data collected from the convenience sample will be presented. It is planned that results of this study will be published following its completion. There is no plan to inform participants of their individual data. The rationale for this is that this is an experimental testing platform, and it is unknown what the findings mean in the context of an individual participants' medical care. However, a letter summarising the group data will be developed and following approval by the IRB, given to all participants.