"Invasive pulmonary fungal infection" AND "fungal lung infection" "Fungal infection"
Conditions
Interventions
HRCT-scan
Sponsors
Prinses Máxima Centrum voor Kinderoncologie
Eligibility
Age
No minimum to 64 Years
Inclusion criteria
Inclusion criteria: Children from 0 up to and including 18 years with a hemato-oncological maligancy or post-HSCT and diagnosed with a possible, probable or proven invasive aspergillosis
Exclusion criteria
Exclusion criteria: Refusal to give informed consent For part 1: A pulmonary co-infection with a non-fungal pathogen, which could also explain the radiological abnormalities. A disease with increased sensitivity for radiation (e.g. fanconi anaemia) Patient is unable to undergo a HRCT scan without anaesthesia A clinical condition causing significant additional burden (e.g. dialysis, mechanical ventilation) at moment of the additional HRCT-scan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Radiological imaging The change in volume of the lesions on the serial HRCT scans will be used as primary endpoint. The volume of the lesions on day 7, 14, 28 and 42 (each) will be compared to the baseline scan on day 0. Secondly, the lesion volume of the follow up scans (t=7, t=14, t=28, t=42) will be compared to the precedent scan. This gives 7 pairwise comparisons in total. New lesions formed during the follow-up period will not be included in this endpoint. 2. Comparison of a new diagnostic test to the current SOC: The novel method of cfDNA to detect IFD will be compared to the SOC diagnostics. Each test will give a positive or negative rest result for the detection of IFD for patient. The SOC will be done on both BAL fluid and blood and a positive rest result is defined as a probable/proven classification following the EORTC criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| For patients participating in main study objective 1: We hypothesize that other radiologic markers will help differentiating in the probability of an IFD and in the course of the disease. With this study we want to explore and identify which radiological imaging characteristics are most sensitive for the course of the fungal disease. Secondly, we hypothesize that the addition of a scan on day 7 will give an improved estimation for outcome and has an additional value in the fungal monitoring compared to a first follow up scan on day 14 (standard of care). For patients participating in main study objective 2: We hypothesize that molecular markers and host-derived markers (besides cf-DNA sequencing) are present in blood and BAL fluid that can be used in the detection or exclusion of fungal infections and can improve the standard diagnostic methods of fungal infections. The (follow-up) blood samples and BAL samples will be used to explore the measurement of therapy response by biological samples and additional molecular detection methods for IFD (besides cfDNA sequencing). This study is the ideal setting in which new diagnostic molecular methods should be tested. The sample collection can be done with a minimal burden to the patient since a central line is placed and regular clinical blood checks are indicated. The study includes the population for which improved diagnostic tools is most valuable. Testing this novel technique in a broader population hopefully leads to improved fungal diagnostics that can benefit future patients within the same population. | — |
Countries
Netherlands
Contacts
Public ContactC.M. Zwaan
Prinses Máxima Centrum voor Kinderoncologie
Outcome results
None listed