Profiling Neutrophil Counts in Patients on Chemotherapy
Profiling Neutrophil Counts in Patients With Cancer During Cycle One of Chemotherapy
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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). |
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.
Ostatní jména:
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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). |
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.
Ostatní jména:
|
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Prophylactic GCSF
Patients on primary prophylactic granulocyte colony stimulating factor (GCSF). The intervention is home finger-prick capillary blood count monitoring (up to daily). |
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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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The proportion of patients from whom sufficient neutrophil counts are obtained during the first cycle of chemotherapy.
Časové okno: 18 months
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18 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The proportion of patients who are diagnosed with severe neutropenia (CTCAE v4.0 grade 3 or 4 neutropenia) and its complications.
Časové okno: 18 months
|
18 months
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The changes in neutrophil counts early in the first cycle of chemotherapy that determine the risk of severe neutropenia and its complications.
Časové okno: 18 months
|
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.
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18 months
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The proportion of patients who decline to enter the study or withdraw from it due to finger-prick capillary sampling.
Časové okno: 18 months
|
18 months
|
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The changes in neutrophil counts early in the first cycle of chemotherapy that determine the risk of severe neutropenia and its complications, when primary prophylactic granulocyte colony stimulating factor is administered.
Časové okno: 18 months
|
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.
|
18 months
|
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The proportion of patients in whom the neutrophil count does not reach grade 1 neutropenia or worse.
Časové okno: 18 months
|
18 months
|
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The proportion of patients in whom the neutrophil count surpasses the threshold for re-treatment in advance of their planned cycle 2 date.
Časové okno: 18 months
|
18 months
|
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The proportion of patients in whom the neutrophil count is below the threshold for retreatment when cycle 2 is due to be delivered.
Časové okno: 18 months
|
18 months
|
|
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Estimate cost implications of using home neutrophil count monitoring during chemotherapy using Markov modelling.
Časové okno: 18 months
|
The trial data will inform the decision ratios in the Markov model.
Aggregated costs associated with each pathway have been calculated using Health Resource grouper software for finished consultant episodes from an audit of patients receiving chemotherapy over a 10 year period at a large Cancer Centre in the United Kingdom.
The real numbers and potential numbers in each pathway will be compared to estimate the cost implications.
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18 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Geoff Hall, FRCP, PhD, University of Leeds
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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. Erratum In: Lancet 2000 Dec 23-30;356(9248):2196.
- Rao 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.
- Rao, 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MO16/191
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