DiagnosticSASANCT03495570
Sysmex-XN 20 Analyser to Assess Lymphocyte Subsets and Other Haematological Parameters in Chronic/Acute Viral Infections
An observational study of Diagnostic and Chronic Viral Hepatitis B, run by University College, London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnostic, Chronic Viral Hepatitis B, Chronic Hepatitis C
- What is being tested?
- blood draw
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Apr 2018to 15 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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:
- 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.
Who cannot join
- On immunosuppressants and/or receiving chemotherapy or radiotherapy for a malignancy;
- Intercurrent infection within the prior 30 days (e.g. influenza like illness).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Mortimer Market centre
London, WC1E 6JB
Sarah L Pett, MD/PhD, 0203 108 2081, s.pett@ucl.ac.uk
Andrea Cartier, BA, 0203 108 2081, a.cartier@ucl.ac.uk
About this study
Official title: 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,
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.
Read the detailed 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 ):
- % lymphocytes in the D1 area of the XN WDF channel;
- % lymphocytes in the D2 area of the XN WDF channel;
- % lymphocytes in the D0 area of the XN WDF channel;
- correlation between CD4+ T-cells (as measured by standard flow cytometry) and the D1+D2 area on the XN WDF channel;
- correlation between CD8+ T-cells (as measured by standard flow cytometry) and the D1+D2 area on the XN WDF channel;
- correlation between CD4+ T-cells (as measured by standard flow cytometry) and the W1/W2 area on the XN WPC channel;
- 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.
- Being tested
- blood draw
- Keywords
- immunological
- Medical subject headings
- Disease, Hepatitis B, Chronic, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawDiagnostic test
Also called lymphocytes panels as measured by Sysmex XN-20 analyser
single one time blood draw to measure lymphocyte panels included activated lymphocytes using remnant sample from a full blood count
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: blood draw | |
| 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. Receives: Diagnostic Test: blood draw | |
| 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. Receives: Diagnostic Test: blood draw | |
| 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. Receives: Diagnostic Test: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of lymphocytes measured in area D1+D2 of the XN WDF and W1/W2 ratio from the WPC channel.
Measured: Day 1
Secondary outcomes (6)
% lymphocytes in the D1 and D2 area of the XN WDF channel
as above
Measured: Day 1
% lymphocytes in the D0 area of the XN WDF channel;
as above
Measured: Day 1
correlation between CD4+ T-cells (as measured by standard flow cytometry) and the D1+D2 area on the XN WDF channel;
as above
Measured: Day 1
correlation between CD8+ T-cells (as measured by standard flow cytometry) and the D1+D2 area on the XN WDF channel;
as above
Measured: Day 1
correlation between CD4+ T-cells (as measured by standard flow cytometry) and the W1/W2 area on the XN WPC channel;
as above
Measured: Day 1
correlation between CD8+ T-cells (as measured by standard flow cytometry) and the W1/W2 area on the XN WPC channel;
as above
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start15 Apr 2018 (estimated)
- Primary completion15 Aug 2018 (estimated)
- Study completion15 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiagnosticStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Central and North West London NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Sarah L Pett, MD/PhD, Study chair, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495570
- Sponsor's protocol ID
- UCL 17/0634
- Acronym
- SASA
- Status last verified
- Mar 2018
- First submitted
- 21 Mar 2018
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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,
- ClinicalTrials.gov ID
- NCT03495570
- Acronym / sponsor ID
- SASA / UCL 17/0634
- Keywords
- immunological
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Central and North West London NHS Foundation Trust
- Study start
- 15 Apr 2018 (estimated)
- Primary completion
- 15 Aug 2018 (estimated)
- Study completion
- 15 Oct 2018 (estimated)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 ):
- % lymphocytes in the D1 area of the XN WDF channel;
- % lymphocytes in the D2 area of the XN WDF channel;
- % lymphocytes in the D0 area of the XN WDF channel;
- correlation between CD4+ T-cells (as measured by standard flow cytometry) and the D1+D2 area on the XN WDF channel;
- correlation between CD8+ T-cells (as measured by standard flow cytometry) and the D1+D2 area on the XN WDF channel;
- correlation between CD4+ T-cells (as measured by standard flow cytometry) and the W1/W2 area on the XN WPC channel;
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | – | Diagnostic Test: blood drawHIV-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 | – | Diagnostic Test: blood drawHIV-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 | – | Diagnostic Test: blood drawHCV 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 | – | Diagnostic Test: blood drawHBV 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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;
- 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.
Key exclusion criteria (2 listed)
- On immunosuppressants and/or receiving chemotherapy or radiotherapy for a malignancy;
- Intercurrent infection within the prior 30 days (e.g. influenza like illness).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawAlso: lymphocytes panels as measured by Sysmex XN-20 analysersingle one time blood draw to measure lymphocyte panels included activated lymphocytes using remnant sample from a full blood count | Diagnostic test | A, B, C, D |
Primary outcome
Percentage of lymphocytes measured in area D1+D2 of the XN WDF and W1/W2 ratio from the WPC channel.
Time frame: Day 1
6 secondary outcomes
% lymphocytes in the D1 and D2 area of the XN WDF channel
Time frame: Day 1
% lymphocytes in the D0 area of the XN WDF channel;
Time frame: Day 1
correlation between CD4+ T-cells (as measured by standard flow cytometry) and the D1+D2 area on the XN WDF channel;
Time frame: Day 1
correlation between CD8+ T-cells (as measured by standard flow cytometry) and the D1+D2 area on the XN WDF channel;
Time frame: Day 1
correlation between CD4+ T-cells (as measured by standard flow cytometry) and the W1/W2 area on the XN WPC channel;
Time frame: Day 1
correlation between CD8+ T-cells (as measured by standard flow cytometry) and the W1/W2 area on the XN WPC channel;
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah L Pett, MD/PhD study chair
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic and Chronic Viral Hepatitis B, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah L Pett, MD/PhD (+44 (0)798 380 6215, s.pett@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of lymphocytes measured in area D1+D2 of the XN WDF and W1/W2 ratio from the WPC channel. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.