NeoplasmsNCT02806557
Profiling Neutrophil Counts in Patients on Chemotherapy
An observational study of Neoplasms and Neutropenia, run by University of Leeds.
Trial summary
The purpose of this trial is to observe the changes in white cell counts in patients with cancer during chemotherapy and to determine if changes in the white cell count in the early days during chemotherapy can be used as a predictor of severe neutropenia and its complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Neutropenia, Febrile Neutropenia
- What is being tested?
- Home finger-prick capillary blood count monitoring
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Mar 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: Adult patients with solid tumours receiving systemic anti-cancer therapy.
Who may be able to join
- Solid tumour diagnosis.
- Adults ≥ 18 years.
- Receiving either single agent or combination cytotoxic chemotherapy alone or in combination with other targeted or immunotherapies.
- Participants can be receiving primary prophylactic antibiotics or GCSF.
- Live within boundaries of Local Care Direct service provision.
Who cannot join
- Inability to give informed consent.
- Concurrent haematological malignancy.
- Known bleeding disorder.
- Known sickle cell disease or β-thalassaemia major.
- Known poorly controlled anti-coagulation (INR >3.5 within 6 months for those on warfarin).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Profiling Neutrophil Counts in Patients With Cancer During Cycle One of Chemotherapy
The purpose of this trial is to observe the changes in white cell counts in patients with cancer during chemotherapy and to determine if changes in the white cell count in the early days during chemotherapy can be used as a predictor of severe neutropenia and its complications.
Read the detailed description
Neutropenia is a low count of the type of white blood cells that fight bacterial infection. It is a common toxicity of chemotherapy given for cancer. When complicated by infection, it can necessitate urgent admission to hospital, and can be life-threatening. Recovery of neutrophils is necessary prior to delivery of further chemotherapy. The information available on the changes of neutrophils during chemotherapy is limited by the frequency of blood tests which have historically required a venous blood sample and hence are burdensome to the patient.
There are point-of-care medical devices which measure the white blood cell count from a capillary finger-prick sample, and can be used in the patient's home. The investigators aim to use such a device in this trial to; (i) observe the changes in white cell counts following chemotherapy delivery, (ii) determine if changes in the white cell count in the early days during chemotherapy can be used as a predictor of severe neutropenia and its complications.
This trial forms part of a larger project in which the investigators are exploring the role of home blood count monitoring in the management of severe neutropenia and its complications, and exploring the potential for home blood count monitoring to be used to optimise the dose intensity and density of chemotherapy.
This is a non-randomised trial in adults with solid tumours, recruiting from Leeds Teaching Hospitals NHS Trust only. Consenting participants are required to have regular finger-prick blood tests up to a maximum frequency of daily for the duration of the first cycle of chemotherapy, most commonly 3 weeks. A nurse will visit the participant at home and use the Hemocue® WBC DIFF to perform the test.
This trial is funded by a Technology Strategy Board (Innovate UK) Small Business Research Initiative grant.
- Conditions
- Neoplasms, Neutropenia, Febrile Neutropenia
- Being tested
- Home finger-prick capillary blood count monitoring
- Keywords
- Neoplasms, Neutropenia, drug therapy, Hematologic tests, Point-of-care Systems, Febrile neutropenia
- Medical subject headings
- Neoplasms, Neutropenia, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home finger-prick capillary blood count monitoringDevice
Also called Hemocue® WBC DIFF
A nurse will visit the participant's home according to the test schedule (up to a maximum frequency of 21 visits in a 21-day cycle) and perform the finger-prick capillary blood test and measure the neutrophil count using the Hemocue® WBC DIFF device.
| Study group | Role | What they receive |
|---|---|---|
| High risk group | Defined as risk of severe neutropenia >20% or risk of neutropenic infective complications >10%, with severe neutropenia defined as absolute neutrophil count <1.0 x10^9/L.
The intervention is home finger-prick capillary blood count monitoring (up to daily). Receives: Device: Home finger-prick capillary blood count monitoring | |
| Frequently given regimens | Defined as high number of cases of neutropenia, but risk of severe neutropenia <5%.
The intervention is home finger-prick capillary blood count monitoring (up to daily). Receives: Device: Home finger-prick capillary blood count monitoring | |
| Prophylactic GCSF | Patients on primary prophylactic granulocyte colony stimulating factor (GCSF).
The intervention is home finger-prick capillary blood count monitoring (up to daily). Receives: Device: Home finger-prick capillary blood count monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients from whom sufficient neutrophil counts are obtained during the first cycle of chemotherapy.
Measured: 18 months
Secondary outcomes (2)
The proportion of patients who are diagnosed with severe neutropenia (CTCAE v4.0 grade 3 or 4 neutropenia) and its complications.
Measured: 18 months
The changes in neutrophil counts early in the first cycle of chemotherapy that determine the risk of severe neutropenia and its complications.
Critical time points for measuring neutrophil counts will be determined dependent upon patterns of neutrophil changes observed and the gradient of neutrophil changes will be categorized according to limits determined by logistic regression modelling and hazard ratio calculations.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, Dr Geoff Hall, University of Leeds
- Investigators
- Geoff Hall, FRCP, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806557
- Sponsor's protocol ID
- MO16/191
- Status last verified
- Jul 2016
- First submitted
- 26 May 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bodey GP, Buckley M, Sathe YS, Freireich EJ. Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia. Ann Intern Med. 1966 Feb;64(2):328-40. doi: 10.7326/0003-4819-64-2-328. No abstract available.
PubMed 5216294Rao LV, Ekberg BA, Connor D, Jakubiak F, Vallaro GM, Snyder M. Evaluation of a new point of care automated complete blood count (CBC) analyzer in various clinical settings. Clin Chim Acta. 2008 Mar;389(1-2):120-5. doi: 10.1016/j.cca.2007.12.006. Epub 2007 Dec 14.
PubMed 18187044Rao, L.V., Moiles, D., Vallero, G.M. and Snyder, M. Finger-Stick Complete Blood Counts: comparison between venous and capillary blood. Point of Care The Journal of Near-Patient Testing & Technology. 2011, 10(3), pp.120-122.
Bergh J, Wiklund T, Erikstein B, Lidbrink E, Lindman H, Malmstrom P, Kellokumpu-Lehtinen P, Bengtsson NO, Soderlund G, Anker G, Wist E, Ottosson S, Salminen E, Ljungman P, Holte H, Nilsson J, Blomqvist C, Wilking N. Tailored fluorouracil, epirubicin, and cyclophosphamide compared with marrow-supported high-dose chemotherapy as adjuvant treatment for high-risk breast cancer: a randomised trial. Scandinavian Breast Group 9401 study. Lancet. 2000 Oct 21;356(9239):1384-91. doi: 10.1016/s0140-6736(00)02841-5.
PubMed 11052580
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling Neutrophil Counts in Patients With Cancer During Cycle One of Chemotherapy
- ClinicalTrials.gov ID
- NCT02806557
- Acronym / sponsor ID
- MO16/191
- Conditions
- Neoplasms, Neutropenia, Febrile Neutropenia
- Keywords
- Neoplasms, Neutropenia, drug therapy, Hematologic tests, Point-of-care Systems, Febrile neutropenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- Sep 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 20 Jun 2016 (estimated)
- 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 purpose of this trial is to observe the changes in white cell counts in patients with cancer during chemotherapy and to determine if changes in the white cell count in the early days during chemotherapy can be used as a predictor of severe neutropenia and its complications.
Detailed description
Neutropenia is a low count of the type of white blood cells that fight bacterial infection. It is a common toxicity of chemotherapy given for cancer. When complicated by infection, it can necessitate urgent admission to hospital, and can be life-threatening. Recovery of neutrophils is necessary prior to delivery of further chemotherapy. The information available on the changes of neutrophils during chemotherapy is limited by the frequency of blood tests which have historically required a venous blood sample and hence are burdensome to the patient.
There are point-of-care medical devices which measure the white blood cell count from a capillary finger-prick sample, and can be used in the patient's home. The investigators aim to use such a device in this trial to; (i) observe the changes in white cell counts following chemotherapy delivery, (ii) determine if changes in the white cell count in the early days during chemotherapy can be used as a predictor of severe neutropenia and its complications.
This trial forms part of a larger project in which the investigators are exploring the role of home blood count monitoring in the management of severe neutropenia and its complications, and exploring the potential for home blood count monitoring to be used to optimise the dose intensity and density of chemotherapy.
This is a non-randomised trial in adults with solid tumours, recruiting from Leeds Teaching Hospitals NHS Trust only. Consenting participants are required to have regular finger-prick blood tests up to a maximum frequency of daily for the duration of the first cycle of chemotherapy, most commonly 3 weeks. A nurse will visit the participant at home and use the Hemocue® WBC DIFF to perform the test.
This trial is funded by a Technology Strategy Board (Innovate UK) Small Business Research Initiative grant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High risk group | – | Device: Home finger-prick capillary blood count monitoringDefined as risk of severe neutropenia >20% or risk of neutropenic infective complications >10%, with severe neutropenia defined as absolute neutrophil count <1.0 x10^9/L. The intervention is home finger-prick capillary blood count monitoring (up to daily). |
| Frequently given regimens | – | Device: Home finger-prick capillary blood count monitoringDefined as high number of cases of neutropenia, but risk of severe neutropenia <5%. The intervention is home finger-prick capillary blood count monitoring (up to daily). |
| Prophylactic GCSF | – | Device: Home finger-prick capillary blood count monitoringPatients on primary prophylactic granulocyte colony stimulating factor (GCSF). The intervention is home finger-prick capillary blood count monitoring (up to daily). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with solid tumours receiving systemic anti-cancer therapy.
Key inclusion criteria (5 listed)
- Solid tumour diagnosis.
- Adults ≥ 18 years.
- Receiving either single agent or combination cytotoxic chemotherapy alone or in combination with other targeted or immunotherapies.
- Participants can be receiving primary prophylactic antibiotics or GCSF.
- Live within boundaries of Local Care Direct service provision.
Key exclusion criteria (5 listed)
- Inability to give informed consent.
- Concurrent haematological malignancy.
- Known bleeding disorder.
- Known sickle cell disease or β-thalassaemia major.
- Known poorly controlled anti-coagulation (INR >3.5 within 6 months for those on warfarin).
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 |
|---|---|---|
| Home finger-prick capillary blood count monitoringAlso: Hemocue® WBC DIFFA nurse will visit the participant's home according to the test schedule (up to a maximum frequency of 21 visits in a 21-day cycle) and perform the finger-prick capillary blood test and measure the neutrophil count using the Hemocue® WBC DIFF device. | Device | Frequently given regimens, High risk group, Prophylactic GCSF |
Primary outcome
The proportion of patients from whom sufficient neutrophil counts are obtained during the first cycle of chemotherapy.
Time frame: 18 months
2 secondary outcomes
The proportion of patients who are diagnosed with severe neutropenia (CTCAE v4.0 grade 3 or 4 neutropenia) and its complications.
Time frame: 18 months
The changes in neutrophil counts early in the first cycle of chemotherapy that determine the risk of severe neutropenia and its complications.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Background: PubMed 5216294Bodey GP, Buckley M, Sathe YS, Freireich EJ. Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia. Ann Intern Med. 1966 Feb;64(2):328-40. doi: 10.7326/0003-4819-64-2-328. No abstract available.
- Background: PubMed 18187044Rao LV, Ekberg BA, Connor D, Jakubiak F, Vallaro GM, Snyder M. Evaluation of a new point of care automated complete blood count (CBC) analyzer in various clinical settings. Clin Chim Acta. 2008 Mar;389(1-2):120-5. doi: 10.1016/j.cca.2007.12.006. Epub 2007 Dec 14.
- BackgroundRao, L.V., Moiles, D., Vallero, G.M. and Snyder, M. Finger-Stick Complete Blood Counts: comparison between venous and capillary blood. Point of Care The Journal of Near-Patient Testing & Technology. 2011, 10(3), pp.120-122.
- Background: PubMed 11052580Bergh J, Wiklund T, Erikstein B, Lidbrink E, Lindman H, Malmstrom P, Kellokumpu-Lehtinen P, Bengtsson NO, Soderlund G, Anker G, Wist E, Ottosson S, Salminen E, Ljungman P, Holte H, Nilsson J, Blomqvist C, Wilking N. Tailored fluorouracil, epirubicin, and cyclophosphamide compared with marrow-supported high-dose chemotherapy as adjuvant treatment for high-risk breast cancer: a randomised trial. Scandinavian Breast Group 9401 study. Lancet. 2000 Oct 21;356(9239):1384-91. doi: 10.1016/s0140-6736(00)02841-5.
- Individual participant dataSharing planned: No
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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.
Geoff Hall, FRCP, PhD principal investigator
University of Leeds
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Neutropenia, run by University of Leeds.
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 5 inclusion and 5 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 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Geoff Hall, FRCP, PhD (+44 113 2068970, g.hall@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients from whom sufficient neutrophil counts are obtained during the first cycle of chemotherapy. (time frame: 18 months). 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 NCT02806557, which also lists 4 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 1 Aug 2016.