hematological malignancies blood cancer
Conditions
Interventions
BreathBase of Breathomix.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: = 18 yearsTreatment with CAR T-cell therapy, autologous- of allogeneic stem cell transplantation or intensive chemotherapy with an expected neutropenic period of at least 7 daysPatient can read and speak Dutch
Exclusion criteria
Exclusion criteria: Transferred from the emergency department with complication related to their hematology treatmentPatients unable to perform an eNose measurement (as determined by someone from the research team)Patients that cannot give informed consentPrior participation in the studyPatients with a recent chest surgeryFever (temperature >38.4°C once or >38.0°C twice with a minimum of 1 hour in between measurements) upon admission to the hospitalAbsolute neutrophil count (ANC) <0.5 *109/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the performance of the predictive model in identifying any type of infection in patients with fever receiving intensive hematological care. Performance will be evaluated using the following metrics: accuracy, sensitivity, specificity, PPV, NPV and ROC curve including the AUC. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Performance of the model, measured as accuracy, sensitivity, specificity, positive predictive value and negative predictive value and receiver operating characteristics including area under the curve to predict sepsis in patients with fever and a deterioration of two or more Sequential Organ Failure Assessment (SOFA) point receiving intensive hematological care- Performance of the model, measured as accuracy, sensitivity, specificity, positive predictive value and negative predictive value and receiver operating characteristics including area under the curve to predict aspergillosis based on the baseline breath profile in patients receiving intensive hematological care- Performance of the model, measured as accuracy, sensitivity, specificity, positive predictive value and negative predictive value and receiver operating characteristics including area under the curve to predict cytokine release syndrome in patients with fever receiving CAR T-cell therapy | — |
Countries
Netherlands
Contacts
Public ContactM Tienstra
Universitair Medisch Centrum Groningen
Outcome results
None listed