Clinical trial · Observational
Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.
Study to Investigate Which Clinical Risk Factors Are Considered by Physicians When Conducting Overall Febrile Neutropenia Risk Assessments for Patients Receiving Chemotherapy With an Intermediate (10% - 20%) Febrile Neutropenia Risk.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy. Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest. Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited. This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Febrile Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- All patients enrolled
Primary outcomes (4)
- measure
- Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia
- timeFrame
- Baseline (prior to participant enrolment)
- description
- During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall febrile neutropenia (FN) risk. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
- measure
- Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old * Any stage NHL, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), or breast cancer initiating a new chemotherapy course * Scheduled to receive one of the permitted standard dose chemotherapy regimens with an estimated intermediate (10%-20%) FN risk according to published data or guidelines (planned dose modifications +/-10% are allowable). * Before any study-specific procedure, the appropriate written informed consent must be obtained where this is required by local regulations Exclusion Criteria: * Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the European Medicines Agency (EMA) or competent authority for any indication, * Ongoing or planned concurrent participation in any clinical study where the administration of Colony Stimulating Factor (CSF) is determined by the protocol (clinical trials on an approved drug and observational trials are permitted as long as these do not mandate how neutropenia should be treated) * Prior stem-cell transplantation (includes bone marrow transplantation)
References
Publications (2)
- BACKGROUNDFreyer G, Kalinka-Warzocha E, Syrigos K, Marinca M, Tonini G, Ng SL, Wong ZW, Salar A, Steger G, Abdelsalam M, DeCosta L, Szabo Z. Attitudes of physicians toward assessing risk and using granulocyte colony-stimulating factor as primary prophylaxis in patients receiving chemotherapy associated with an intermediate risk of febrile neutropenia. Med Oncol. 2015 Oct;32(10):236. doi: 10.1007/s12032-015-0682-z. Epub 2015 Aug 28. PMID 26315712
- DERIVEDLyman GH, Dale DC, Legg JC, Abella E, Morrow PK, Whittaker S, Crawford J. Assessing patients' risk of febrile neutropenia: is there a correlation between physician-assessed risk and model-predicted risk? Cancer Med. 2015 Aug;4(8):1153-60. doi: 10.1002/cam4.454. Epub 2015 Mar 23. PMID 25810005