Suspected Neutropenic FeverDUCATIS - S1NCT07901660
Diagnostic Accuracy, Clinical Utility and Implementation of Point-of-Care Absolute Neutrophil Count in Suspected Neutropenic Fever (DUCATIS) - Diagnostic Accuracy (S1)
A study testing Hemocue® WBC DIFF system in people with Suspected Neutropenic Fever and Confirmed Neutropenic Fever, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Study 1 (S1). In a range of adult patients with sNF and controls, there is no significant difference between the POC-ANC and laboratory analyser. The diagnostic study will be performed 24 hours a day. Informed consent will be sought from every patient for a finger prick (capillary blood) and venous blood sample. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suspected Neutropenic Fever, Confirmed Neutropenic Fever, Severe Neutropenic Fever
- What is being tested?
- Hemocue® WBC DIFF system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2027to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- ≥18 years; AND
- Suspected low ANC; AND
- Stable.
Who cannot join
- No consent obtained
- Blood sampling my hinder the management of the patient according to the doctor or nurse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Queen Mary Hospital
Hong Kong
Timothy Rainer, 39176846, thrainer@hku.hk
About this study
Study 1 (S1). In a range of adult patients with sNF and controls, there is no significant difference between the POC-ANC and laboratory analyser.
The diagnostic study will be performed 24 hours a day. Informed consent will be sought from every patient for a finger prick (capillary blood) and venous blood sample.
Briefly, paired capillary (finger prick) and venous EDTA blood samples will be obtained from 317 patients meeting the inclusion criteria.
Prospective diagnostic accuracy study. The target accuracy index is the lower 95%CI of sensitivity, although we evaluate other important factors of diagnostic accuracy (see data analysis below).
Read the detailed description
Questions
In ED and hospitalised adult cancer patients with sNF, is a POC-ANC sufficiently accurate as a diagnostic test compared with a laboratory gold standard?
Primary hypotheses
Study 1 (S1). In a range of adult patients with sNF and controls, there is no significant difference between the POC-ANC and laboratory analyser.
Definitions
Suspected neutropenic fever (sNF) refers to fever after myelosuppressive cancer treatment in a patient in whom neutropenia is suspected, before laboratory confirmation.
The definition of NF varies across different international guidelines. In this proposal, NF is defined as an ANC <1.0 × 10⁹/L and fever with a single oral temperature of ≥38.3°C (101°F) or a temperature of ≥38.0°C (100.4°F) sustained over a one-hour period after myelosuppressive cancer treatment in the ED or within 24 hours prior to ED registration. However, some guidelines and oncologists set the definition of NF at <0.5 × 10⁹/L.
Severe neutropenia is defined as an ANC <0.5 × 10⁹/L. This NF definition leaves a safety margin with an anticipation that some patients with an initial ANC of 0.5-1.0 × 10⁹/L may progress to severe neutropenia over the next 48 hours.
Thus, sNF patients will be further categorised into severe NF (ANC <0.5 × 10⁹/L), non-severe NF (ANC 0.5-1.0 × 10⁹/L) and non-NF (ANC ≥1.0 × 10⁹/L) for comparison.
S1. Diagnostic Accuracy
The diagnostic study will be performed 24 hours a day. Informed consent will be sought from every patient for a finger prick (capillary blood) and venous blood sample.
We use methods as previously reported by Russcher [16]. Briefly, paired capillary (finger prick) and venous EDTA blood samples will be obtained from 317 patients meeting the inclusion criteria. Reference counts (Gold standard) will be obtained by a standardised Sysmex XE-5000 automated cell counter (Sysmex Corporation, Kobe, Japan). All samples will be analysed in duplicates on the HemoCue WBC DIFF system and in single replicate on the Sysmex XE-5000 within 8 hours after collection. The timespan between analyses on both systems should be less than 2 hours for each sample.
Justification for evaluating capillary blood
It is important to evaluate the accuracy of capillary blood as the POCANC device might find a use in other settings e.g. clinics, or home use.
Outcomes
Prospective diagnostic accuracy study. The target accuracy index is the lower 95%CI of sensitivity, although we evaluate other important factors of diagnostic accuracy (see data analysis below).
Data processing
The primary analysis is on sensitivity of 97 - 99.9% looking to safely rule out NF.
In addition we will evaluate accuracy of the ANC aiming for the slope for linear regression between both test and reference methods no more than ± 5% (r≥0.95).
We will also calculate pooled standard deviations (SD) and coefficient variations (CV). We will report the SD/CV and Bland-Altman Limits of acceptance (LoA) aiming for <15%. All the data will be analysed using orthogonal regression analysis (Deming regression) and Pearson's correlation coefficient (r).
We will also report intra-and inter-class variation, inter-hospital laboratory variation (where available), specificity, AUC, NPV and PPV.
Missing Data
Patients with missing laboratory or POCT ANC data will be excluded from data analysis. For POCT ANC values below lower limit of detection leading to the absence of a numerical value, pairwise correlation analysis will not be performed. Other missing values will not be imputed.
Ethics approval
This study has been approved by the Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB; reference number: UW 25-660).
- Conditions
- Suspected Neutropenic Fever, Confirmed Neutropenic Fever, Severe Neutropenic Fever, Neutropenic Fever, Febrile Neutropenia, Febrile Neutropenia (FN)
- Being tested
- Hemocue® WBC DIFF system
- Keywords
- DUCATIS, neutropenic fever, febrile neutropenia, point-of-care, diagnostic accuracy, neutrophil, absolute neutrophil count, ANC
- Medical subject headings
- Febrile Neutropenia, Neutropenia, Leukopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemocue® WBC DIFF systemDiagnostic test
Also called POC-ANC, POCT-ANC
Briefly, paired capillary (finger prick) and venous EDTA blood samples will be obtained from 317 patients meeting the inclusion criteria. Reference counts (Gold standard) will be obtained by a standardised Sysmex XE-5000 automated cell counter (Sysmex Corporation, Kobe, Japan). All samples will be analysed in duplicates on the HemoCue WBC DIFF system and in single replicate on the Sysmex XE-5000 within 8 hours after collection. The timespan between analyses on both systems should be less than 2 hours for each sample.
| Study group | Role | What they receive |
|---|---|---|
| Consented participants | Experimental | S1. Adult patients with suspected low ANC in the ED or admitted to medical wards.
1. ≥18 years; AND
2. Suspected low ANC; AND
3. Stable Receives: Diagnostic Test: Hemocue® WBC DIFF system |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of POC-ANC compared with the laboratory reference method
The target accuracy index is the lower 95%CI of sensitivity, although we evaluate other important factors of diagnostic accuracy (see data analysis below).
The primary analysis is on sensitivity of 97 - 99.9% looking to safely rule out NF.
Measured: All samples will be analysed in duplicates on the HemoCue WBC DIFF system and in single replicate on the Sysmex XE-5000 within 8 hours after collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Suspected Neutropenic FeverStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study Design S1. Prospective diagnostic accuracy of POC-ANC; S1. Diagnostic Accuracy The diagnostic study will be performed 24 hours a day. Informed consent will be sought from every patient for a finger prick (capillary blood) and venous blood sample. We use methods as previously reported by Russcher \[16\]. Briefly, paired capillary (finger prick) and venous EDTA blood samples will be obtained from 317 patients meeting the inclusion criteria. Reference counts (Gold standard) will be obtained by a standard¬ised Sysmex XE-5000 automated cell counter (Sysmex Corporation, Kobe, Japan). All samples will be analysed in duplicates on the HemoCue WBC DIFF system and in single replicate on the Sysmex XE-5000 within 8 hours after collection. The timespan between analyses on both systems should be less than 2 hours for each sample.
- Masking
- None (open label)
- Enrolment
- 317 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Timothy Hudson RAINER, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901660
- Sponsor's protocol ID
- DUCATIS - S1
- Other IDs
- HMRF
- Acronym
- DUCATIS - S1
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Weycker D, Li X, Edelsberg J, Barron R, Kartashov A, Xu H, Lyman GH. Risk and Consequences of Chemotherapy-Induced Febrile Neutropenia in Patients With Metastatic Solid Tumors. J Oncol Pract. 2015 Jan;11(1):47-54. doi: 10.1200/JOP.2014.001492. Epub 2014 Dec 9.
PubMed 25491042Culakova E, Thota R, Poniewierski MS, Kuderer NM, Wogu AF, Dale DC, Crawford J, Lyman GH. Patterns of chemotherapy-associated toxicity and supportive care in US oncology practice: a nationwide prospective cohort study. Cancer Med. 2014 Apr;3(2):434-44. doi: 10.1002/cam4.200. Epub 2014 Feb 17.
PubMed 24706592Klastersky J, Ameye L, Maertens J, Georgala A, Muanza F, Aoun M, Ferrant A, Rapoport B, Rolston K, Paesmans M. Bacteraemia in febrile neutropenic cancer patients. Int J Antimicrob Agents. 2007 Nov;30 Suppl 1:S51-9. doi: 10.1016/j.ijantimicag.2007.06.012. Epub 2007 Aug 8.
PubMed 17689933Caggiano V, Weiss RV, Rickert TS, Linde-Zwirble WT. Incidence, cost, and mortality of neutropenia hospitalization associated with chemotherapy. Cancer. 2005 May 1;103(9):1916-24. doi: 10.1002/cncr.20983.
PubMed 15751024Taplitz RA, Kennedy EB, Bow EJ, Crews J, Gleason C, Hawley DK, Langston AA, Nastoupil LJ, Rajotte M, Rolston K, Strasfeld L, Flowers CR. Outpatient Management of Fever and Neutropenia in Adults Treated for Malignancy: American Society of Clinical Oncology and Infectious Diseases Society of America Clinical Practice Guideline Update. J Clin Oncol. 2018 May 10;36(14):1443-1453. doi: 10.1200/JCO.2017.77.6211. Epub 2018 Feb 20.
PubMed 29461916Levy MM, Evans LE, Rhodes A. The Surviving Sepsis Campaign Bundle: 2018 update. Intensive Care Med. 2018 Jun;44(6):925-928. doi: 10.1007/s00134-018-5085-0. Epub 2018 Apr 19. No abstract available.
PubMed 29675566Freifeld AG, Bow EJ, Sepkowitz KA, Boeckh MJ, Ito JI, Mullen CA, Raad II, Rolston KV, Young JA, Wingard JR; Infectious Diseases Society of America. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america. Clin Infect Dis. 2011 Feb 15;52(4):e56-93. doi: 10.1093/cid/cir073.
PubMed 21258094Averbuch D, Orasch C, Cordonnier C, Livermore DM, Mikulska M, Viscoli C, Gyssens IC, Kern WV, Klyasova G, Marchetti O, Engelhard D, Akova M; ECIL4, a joint venture of EBMT, EORTC, ICHS, ESGICH/ESCMID and ELN. European guidelines for empirical antibacterial therapy for febrile neutropenic patients in the era of growing resistance: summary of the 2011 4th European Conference on Infections in Leukemia. Haematologica. 2013 Dec;98(12):1826-35. doi: 10.3324/haematol.2013.091025.
PubMed 24323983Baden LR, Swaminathan S, Angarone M, Blouin G, Camins BC, Casper C, Cooper B, Dubberke ER, Engemann AM, Freifeld AG, Greene JN, Ito JI, Kaul DR, Lustberg ME, Montoya JG, Rolston K, Satyanarayana G, Segal B, Seo SK, Shoham S, Taplitz R, Topal J, Wilson JW, Hoffmann KG, Smith C. Prevention and Treatment of Cancer-Related Infections, Version 2.2016, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2016 Jul;14(7):882-913. doi: 10.6004/jnccn.2016.0093.
PubMed 27407129Keck JM, Wingler MJB, Cretella DA, Vijayvargiya P, Wagner JL, Barber KE, Jhaveri TA, Stover KR. Approach to fever in patients with neutropenia: a review of diagnosis and management. Ther Adv Infect Dis. 2022 Nov 26;9:20499361221138346. doi: 10.1177/20499361221138346. eCollection 2022 Jan-Dec.
PubMed 3645193611. HemoCue AB. HemoCue WBC DIFF System [Internet]. Ängelholm: HemoCue AB; [date unknown] [cited 2025 Feb 24]. Available from: https://hemocue.com/en/products/hematology/hemocue-wbc-diff-system/
Peyrony O, Gerlier C, Barla I, Ellouze S, Legay L, Azoulay E, Chevret S, Fontaine JP. Antibiotic prescribing and outcomes in cancer patients with febrile neutropenia in the emergency department. PLoS One. 2020 Feb 28;15(2):e0229828. doi: 10.1371/journal.pone.0229828. eCollection 2020.
PubMed 32109264Mettert K, Lewis C, Dorsey C, Halko H, Weiner B. Measuring implementation outcomes: An updated systematic review of measures' psychometric properties. Implement Res Pract. 2020 Aug 28;1:2633489520936644. doi: 10.1177/2633489520936644. eCollection 2020 Jan-Dec.
PubMed 37089128Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
PubMed 20957426Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
PubMed 10474547
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy, Clinical Utility and Implementation of Point-of-Care Absolute Neutrophil Count in Suspected Neutropenic Fever (DUCATIS) - Diagnostic Accuracy (S1)
- ClinicalTrials.gov ID
- NCT07901660
- Acronym / sponsor ID
- DUCATIS - S1 / DUCATIS - S1
- Conditions
- Suspected Neutropenic Fever, Confirmed Neutropenic Fever, Severe Neutropenic Fever, Neutropenic Fever, Febrile Neutropenia, Febrile Neutropenia (FN)
- Keywords
- DUCATIS, neutropenic fever, febrile neutropenia, point-of-care, diagnostic accuracy, neutrophil, absolute neutrophil count, ANC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 317 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 28 Oct 2026 (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.
Study 1 (S1). In a range of adult patients with sNF and controls, there is no significant difference between the POC-ANC and laboratory analyser.
The diagnostic study will be performed 24 hours a day. Informed consent will be sought from every patient for a finger prick (capillary blood) and venous blood sample.
Briefly, paired capillary (finger prick) and venous EDTA blood samples will be obtained from 317 patients meeting the inclusion criteria.
Prospective diagnostic accuracy study. The target accuracy index is the lower 95%CI of sensitivity, although we evaluate other important factors of diagnostic accuracy (see data analysis below).
Detailed description
Questions
In ED and hospitalised adult cancer patients with sNF, is a POC-ANC sufficiently accurate as a diagnostic test compared with a laboratory gold standard?
Primary hypotheses
Study 1 (S1). In a range of adult patients with sNF and controls, there is no significant difference between the POC-ANC and laboratory analyser.
Definitions
Suspected neutropenic fever (sNF) refers to fever after myelosuppressive cancer treatment in a patient in whom neutropenia is suspected, before laboratory confirmation.
The definition of NF varies across different international guidelines. In this proposal, NF is defined as an ANC <1.0 × 10⁹/L and fever with a single oral temperature of ≥38.3°C (101°F) or a temperature of ≥38.0°C (100.4°F) sustained over a one-hour period after myelosuppressive cancer treatment in the ED or within 24 hours prior to ED registration. However, some guidelines and oncologists set the definition of NF at <0.5 × 10⁹/L.
Severe neutropenia is defined as an ANC <0.5 × 10⁹/L. This NF definition leaves a safety margin with an anticipation that some patients with an initial ANC of 0.5-1.0 × 10⁹/L may progress to severe neutropenia over the next 48 hours.
Thus, sNF patients will be further categorised into severe NF (ANC <0.5 × 10⁹/L), non-severe NF (ANC 0.5-1.0 × 10⁹/L) and non-NF (ANC ≥1.0 × 10⁹/L) for comparison.
S1. Diagnostic Accuracy
The diagnostic study will be performed 24 hours a day. Informed consent will be sought from every patient for a finger prick (capillary blood) and venous blood sample.
We use methods as previously reported by Russcher [16]. Briefly, paired capillary (finger prick) and venous EDTA blood samples will be obtained from 317 patients meeting the inclusion criteria. Reference counts (Gold standard) will be obtained by a standardised Sysmex XE-5000 automated cell counter (Sysmex Corporation, Kobe, Japan). All samples will be analysed in duplicates on the HemoCue WBC DIFF system and in single replicate on the Sysmex XE-5000 within 8 hours after collection. The timespan between analyses on both systems should be less than 2 hours for each sample.
Justification for evaluating capillary blood
It is important to evaluate the accuracy of capillary blood as the POCANC device might find a use in other settings e.g. clinics, or home use.
Outcomes
Prospective diagnostic accuracy study. The target accuracy index is the lower 95%CI of sensitivity, although we evaluate other important factors of diagnostic accuracy (see data analysis below).
Data processing
The primary analysis is on sensitivity of 97 - 99.9% looking to safely rule out NF.
In addition we will evaluate accuracy of the ANC aiming for the slope for linear regression between both test and reference methods no more than ± 5% (r≥0.95).
We will also calculate pooled standard deviations (SD) and coefficient variations (CV). We will report the SD/CV and Bland-Altman Limits of acceptance (LoA) aiming for <15%. All the data will be analysed using orthogonal regression analysis (Deming regression) and Pearson's correlation coefficient (r).
We will also report intra-and inter-class variation, inter-hospital laboratory variation (where available), specificity, AUC, NPV and PPV.
Missing Data
Patients with missing laboratory or POCT ANC data will be excluded from data analysis. For POCT ANC values below lower limit of detection leading to the absence of a numerical value, pairwise correlation analysis will not be performed. Other missing values will not be imputed.
Ethics approval
This study has been approved by the Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB; reference number: UW 25-660).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study Design S1. Prospective diagnostic accuracy of POC-ANC; S1. Diagnostic Accuracy The diagnostic study will be performed 24 hours a day. Informed consent will be sought from every patient for a finger prick (capillary blood) and venous blood sample. We use methods as previously reported by Russcher [16]. Briefly, paired capillary (finger prick) and venous EDTA blood samples will be obtained from 317 patients meeting the inclusion criteria. Reference counts (Gold standard) will be obtained by a standard¬ised Sysmex XE-5000 automated cell counter (Sysmex Corporation, Kobe, Japan). All samples will be analysed in duplicates on the HemoCue WBC DIFF system and in single replicate on the Sysmex XE-5000 within 8 hours after collection. The timespan between analyses on both systems should be less than 2 hours for each sample.
| Arm | Type | Receives |
|---|---|---|
| Consented participants | Experimental | Diagnostic Test: Hemocue® WBC DIFF systemS1. Adult patients with suspected low ANC in the ED or admitted to medical wards. 1. ≥18 years; AND 2. Suspected low ANC; AND 3. Stable |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years; AND
- Suspected low ANC; AND
- Stable.
Key exclusion criteria (2 listed)
- No consent obtained
- Blood sampling my hinder the management of the patient according to the doctor or nurse.
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 |
|---|---|---|
| Hemocue® WBC DIFF systemAlso: POC-ANC, POCT-ANCBriefly, paired capillary (finger prick) and venous EDTA blood samples will be obtained from 317 patients meeting the inclusion criteria. Reference counts (Gold standard) will be obtained by a standardised Sysmex XE-5000 automated cell counter (Sysmex Corporation, Kobe, Japan). All samples will be analysed in duplicates on the HemoCue WBC DIFF system and in single replicate on the Sysmex XE-5000 within 8 hours after collection. The timespan between analyses on both systems should be less than 2 hours for each sample. | Diagnostic test | Consented participants |
Primary outcome
sensitivity of POC-ANC compared with the laboratory reference method
Time frame: All samples will be analysed in duplicates on the HemoCue WBC DIFF system and in single replicate on the Sysmex XE-5000 within 8 hours after collection.
The target accuracy index is the lower 95%CI of sensitivity, although we evaluate other important factors of diagnostic accuracy (see data analysis below). The primary analysis is on sensitivity of 97 - 99.9% looking to safely rule out NF.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 25491042Weycker D, Li X, Edelsberg J, Barron R, Kartashov A, Xu H, Lyman GH. Risk and Consequences of Chemotherapy-Induced Febrile Neutropenia in Patients With Metastatic Solid Tumors. J Oncol Pract. 2015 Jan;11(1):47-54. doi: 10.1200/JOP.2014.001492. Epub 2014 Dec 9.
- Background: PubMed 24706592Culakova E, Thota R, Poniewierski MS, Kuderer NM, Wogu AF, Dale DC, Crawford J, Lyman GH. Patterns of chemotherapy-associated toxicity and supportive care in US oncology practice: a nationwide prospective cohort study. Cancer Med. 2014 Apr;3(2):434-44. doi: 10.1002/cam4.200. Epub 2014 Feb 17.
- Background: PubMed 17689933Klastersky J, Ameye L, Maertens J, Georgala A, Muanza F, Aoun M, Ferrant A, Rapoport B, Rolston K, Paesmans M. Bacteraemia in febrile neutropenic cancer patients. Int J Antimicrob Agents. 2007 Nov;30 Suppl 1:S51-9. doi: 10.1016/j.ijantimicag.2007.06.012. Epub 2007 Aug 8.
- Background: PubMed 15751024Caggiano V, Weiss RV, Rickert TS, Linde-Zwirble WT. Incidence, cost, and mortality of neutropenia hospitalization associated with chemotherapy. Cancer. 2005 May 1;103(9):1916-24. doi: 10.1002/cncr.20983.
- Background: PubMed 29461916Taplitz RA, Kennedy EB, Bow EJ, Crews J, Gleason C, Hawley DK, Langston AA, Nastoupil LJ, Rajotte M, Rolston K, Strasfeld L, Flowers CR. Outpatient Management of Fever and Neutropenia in Adults Treated for Malignancy: American Society of Clinical Oncology and Infectious Diseases Society of America Clinical Practice Guideline Update. J Clin Oncol. 2018 May 10;36(14):1443-1453. doi: 10.1200/JCO.2017.77.6211. Epub 2018 Feb 20.
- Background: PubMed 29675566Levy MM, Evans LE, Rhodes A. The Surviving Sepsis Campaign Bundle: 2018 update. Intensive Care Med. 2018 Jun;44(6):925-928. doi: 10.1007/s00134-018-5085-0. Epub 2018 Apr 19. No abstract available.
- Background: PubMed 21258094Freifeld AG, Bow EJ, Sepkowitz KA, Boeckh MJ, Ito JI, Mullen CA, Raad II, Rolston KV, Young JA, Wingard JR; Infectious Diseases Society of America. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america. Clin Infect Dis. 2011 Feb 15;52(4):e56-93. doi: 10.1093/cid/cir073.
- Background: PubMed 24323983Averbuch D, Orasch C, Cordonnier C, Livermore DM, Mikulska M, Viscoli C, Gyssens IC, Kern WV, Klyasova G, Marchetti O, Engelhard D, Akova M; ECIL4, a joint venture of EBMT, EORTC, ICHS, ESGICH/ESCMID and ELN. European guidelines for empirical antibacterial therapy for febrile neutropenic patients in the era of growing resistance: summary of the 2011 4th European Conference on Infections in Leukemia. Haematologica. 2013 Dec;98(12):1826-35. doi: 10.3324/haematol.2013.091025.
- Background: PubMed 27407129Baden LR, Swaminathan S, Angarone M, Blouin G, Camins BC, Casper C, Cooper B, Dubberke ER, Engemann AM, Freifeld AG, Greene JN, Ito JI, Kaul DR, Lustberg ME, Montoya JG, Rolston K, Satyanarayana G, Segal B, Seo SK, Shoham S, Taplitz R, Topal J, Wilson JW, Hoffmann KG, Smith C. Prevention and Treatment of Cancer-Related Infections, Version 2.2016, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2016 Jul;14(7):882-913. doi: 10.6004/jnccn.2016.0093.
- Background: PubMed 36451936Keck JM, Wingler MJB, Cretella DA, Vijayvargiya P, Wagner JL, Barber KE, Jhaveri TA, Stover KR. Approach to fever in patients with neutropenia: a review of diagnosis and management. Ther Adv Infect Dis. 2022 Nov 26;9:20499361221138346. doi: 10.1177/20499361221138346. eCollection 2022 Jan-Dec.
- Background11. HemoCue AB. HemoCue WBC DIFF System [Internet]. Ängelholm: HemoCue AB; [date unknown] [cited 2025 Feb 24]. Available from: https://hemocue.com/en/products/hematology/hemocue-wbc-diff-system/
- Background: PubMed 32109264Peyrony O, Gerlier C, Barla I, Ellouze S, Legay L, Azoulay E, Chevret S, Fontaine JP. Antibiotic prescribing and outcomes in cancer patients with febrile neutropenia in the emergency department. PLoS One. 2020 Feb 28;15(2):e0229828. doi: 10.1371/journal.pone.0229828. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemocue® WBC DIFF system in people with Suspected Neutropenic Fever and Confirmed Neutropenic Fever, run by The University of Hong Kong at 1 site in Hong Kong.
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 3 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: opening soon, as of the sponsor's last update on 28 Oct 2026. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy Rainer (+852 39176846, thrainer@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of POC-ANC compared with the laboratory reference method (time frame: All samples will be analysed in duplicates on the HemoCue WBC DIFF system and in single replicate on the Sysmex XE-5000 within 8 hours after collection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07901660, which also lists 28 linked publications.
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 28 Oct 2026.