Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-03-16 @ 7:33 PM
Study NCT ID:
NCT02806557
Status:
UNKNOWN
Last Update Posted:
2016-08-01
First Post:
2016-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Profiling Neutrophil Counts in Patients on Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D064147', 'term': 'Febrile Neutropenia'}], 'ancestors': [{'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-29', 'studyFirstSubmitDate': '2016-05-26', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The proportion of patients who decline to enter the study or withdraw from it due to finger-prick capillary sampling.', 'timeFrame': '18 months'}, {'measure': '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.', 'timeFrame': '18 months', 'description': '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.'}, {'measure': 'The proportion of patients in whom the neutrophil count does not reach grade 1 neutropenia or worse.', 'timeFrame': '18 months'}, {'measure': 'The proportion of patients in whom the neutrophil count surpasses the threshold for re-treatment in advance of their planned cycle 2 date.', 'timeFrame': '18 months'}, {'measure': 'The proportion of patients in whom the neutrophil count is below the threshold for retreatment when cycle 2 is due to be delivered.', 'timeFrame': '18 months'}, {'measure': 'Estimate cost implications of using home neutrophil count monitoring during chemotherapy using Markov modelling.', 'timeFrame': '18 months', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'The proportion of patients from whom sufficient neutrophil counts are obtained during the first cycle of chemotherapy.', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients who are diagnosed with severe neutropenia (CTCAE v4.0 grade 3 or 4 neutropenia) and its complications.', 'timeFrame': '18 months'}, {'measure': 'The changes in neutrophil counts early in the first cycle of chemotherapy that determine the risk of severe neutropenia and its complications.', 'timeFrame': '18 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neoplasms', 'Neutropenia', 'drug therapy', 'Hematologic tests', 'Point-of-care Systems', 'Febrile neutropenia'], 'conditions': ['Neoplasms', 'Neutropenia', 'Febrile Neutropenia']}, 'referencesModule': {'references': [{'pmid': '5216294', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18187044', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11052580', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThere 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.\n\nThis 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.\n\nThis 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.\n\nThis trial is funded by a Technology Strategy Board (Innovate UK) Small Business Research Initiative grant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with solid tumours receiving systemic anti-cancer therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Solid tumour diagnosis.\n* Adults ≥ 18 years.\n* Receiving either single agent or combination cytotoxic chemotherapy alone or in combination with other targeted or immunotherapies.\n* Participants can be receiving primary prophylactic antibiotics or GCSF.\n* Live within boundaries of Local Care Direct service provision.\n\nExclusion Criteria:\n\n* Inability to give informed consent.\n* Concurrent haematological malignancy.\n* Known bleeding disorder.\n* Known sickle cell disease or β-thalassaemia major.\n* Known poorly controlled anti-coagulation (INR \\>3.5 within 6 months for those on warfarin).'}, 'identificationModule': {'nctId': 'NCT02806557', 'briefTitle': 'Profiling Neutrophil Counts in Patients on Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Leeds'}, 'officialTitle': 'Profiling Neutrophil Counts in Patients With Cancer During Cycle One of Chemotherapy', 'orgStudyIdInfo': {'id': 'MO16/191'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High risk group', 'description': '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.\n\nThe intervention is home finger-prick capillary blood count monitoring (up to daily).', 'interventionNames': ['Device: Home finger-prick capillary blood count monitoring']}, {'label': 'Frequently given regimens', 'description': 'Defined as high number of cases of neutropenia, but risk of severe neutropenia \\<5%.\n\nThe intervention is home finger-prick capillary blood count monitoring (up to daily).', 'interventionNames': ['Device: Home finger-prick capillary blood count monitoring']}, {'label': 'Prophylactic GCSF', 'description': 'Patients on primary prophylactic granulocyte colony stimulating factor (GCSF).\n\nThe intervention is home finger-prick capillary blood count monitoring (up to daily).', 'interventionNames': ['Device: Home finger-prick capillary blood count monitoring']}], 'interventions': [{'name': 'Home finger-prick capillary blood count monitoring', 'type': 'DEVICE', 'otherNames': ['Hemocue® WBC DIFF'], 'description': "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.", 'armGroupLabels': ['Frequently given regimens', 'High risk group', 'Prophylactic GCSF']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Geoff Hall, FRCP, PhD', 'role': 'CONTACT', 'email': 'g.hall@leeds.ac.uk', 'phone': '+44 113 2068970'}, {'name': 'Elaine Dunwoodie, MB ChB', 'role': 'CONTACT', 'email': 'e.h.dunwoodie@leeds.ac.uk', 'phone': '+44 113 2067856'}], 'overallOfficials': [{'name': 'Geoff Hall, FRCP, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leeds'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leeds', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philips Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Geoff Hall', 'investigatorAffiliation': 'University of Leeds'}}}}