I-BALL 2: Non-invasive Disease Monitoring in Infants with Cystic Fibrosis

I-BALL 2: Non-invasive Disease Monitoring in Infants with Cystic Fibrosis - I-BALL 2 study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49034

Enrollment

120

Registered

2020-11-23

Start date

2021-01-12

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CF Cystic Fibrosis

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Subjects are eligible for this study when they are: • Diagnosed with CF, either by abnormal sweat test and/or confirmed with 2 mutations found by genetic analysis, either from heel-prick screening or diagnosed later in life. • Aged 1, 3 or 5 years, when they undergo bronchoscopy and chest CT scan as part of the routine monitoring program for CF. • Aged 1, 2, 3, 4, or 5 years, when they visit the outpatient clinic for routine yearly follow-up, the patient will be eligible for induced Sputum, exhaled breath collection and blood collection for TiMaSCAN. • Authorized by a written informed consent from parents to undergo a sputum induction to collect Induced Sputum (IS), to collect exhaled breath for Volatile Organic Compounds (VOC) analysis, to collect an extra vial of blood during the routine venous puncture, a nasopharyngeal swab (during anesthesia when applicable) and permission to use excess biomaterials, especially BALF retrieved during bronchoscopy and coded clinical data for research. Parents may choose to opt in or out for separate parts of the study.

Exclusion criteria

Exclusion criteria: Absence of previously given informed consent for use of encoded clinical data for scientific purposes.

Design outcomes

Primary

Measure	Time frame
1. Inflammatory markers in BAL, validated against CT score and LCI 2. Inflammatory markers in IS and EB, validated against BAL, CT and LCI. 3. The detection of intracellular pathogens in peripheral blood monocytes using TiMaSCAN, validated	—

Secondary

Measure	Time frame
• Chest CT scores according to the PRAGMA scoring system • Lung Clearance Index as a functional endpoint • Parent reported symptoms will be recorded with the use of a questionnaire. • TiMaSCAN secondary endpoints o Assess agreement between TiMaSCAN results and reported clinical symptoms. o We will determine the prevalence of the different microorganisms that are detected using TiMaSCAN within infected individuals, i.e. those with a positive TiMaSCAN result. This can be determined irrespective of the presence of symptoms. Data on the prevalence of specific pathogens generated using TiMaSCAN will be compared with the results derived from airway cultures.	—

Measure

Time frame

• Chest CT scores according to the PRAGMA scoring system • Lung Clearance Index as a functional endpoint • Parent reported symptoms will be recorded with the use of a questionnaire. • TiMaSCAN secondary endpoints o Assess agreement between TiMaSCAN results and reported clinical symptoms. o We will determine the prevalence of the different microorganisms that are detected using TiMaSCAN within infected individuals, i.e. those with a positive TiMaSCAN result. This can be determined irrespective of the presence of symptoms. Data on the prevalence of specific pathogens generated using TiMaSCAN will be compared with the results derived from airway cultures.

—

Countries

Netherlands

Outcome results