to compare data from nose brush cells and blood cells from CF patients, obtained in the TERRIFIC studie, to the data in healthy controls.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
alle deelnemers zijn gezond
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Expression levels of inflammatory markers expressed on epithelial and immune
cells, abundance of a particular pathogenic cell type in peripheral blood or
plasma levels of inflammatory proteins like cytokines. The inflammatory
response of epithelial cells in vitro to pathogens and the interplay between
the epithelial cells and immune cells obtained from blood in in vitro
co-cultures. Outcomes of these parameters will be a direct comparison to the
outcomes of the TERRIFIC study.
Secondary outcome
not applicable
Background summary
Scientific research conducted at the laboratory of Pulmonary Medicine of the
Erasmus Medical Center includes translational research on immunology, oncology
and vascular diseases. To interpret new findings in patients diseased patients,
comparison with age matched healthy controls in necessary.
Epithelial cells respond to pathogens in our direct environment by secreting
inflammatory mediators that activate the underlying immune cells to exert an
inflammatory response that ultimately leads to pathogen clearance. In
respiratory diseased, including Cystic Fibrosis (CF) and asthma, the epithelial
- immune cell interplay in these diseases, the use of primary healthy material
as a comparison is pivotal. We will use nose brushes for epithelial cell
isolation and blood for the isolation of immune cells. We will measure
expression levels of markers expressed on epithelial and immune cells,
abundance of pathogenic cell types in nasal brushes and blood, the presence of
inflammatory proteins and we will exploit organoid cultures to investigate the
epithelial-immune cell interactions in healthy individuals as a direct
comparison to the TERRIFIC study investigating CF patients. The research
protocol to obtain nose brushes and blood from CF individuals (TERRIFIC
protocol) was already approved in May 2022. The approval of the current HCNB
protocol would allow us to directly compare data obtained from CF individuals
to healthy controls and would aid in identifying possible therapeutic
intervention strategies.
Study objective
to compare data from nose brush cells and blood cells from CF patients,
obtained in the TERRIFIC studie, to the data in healthy controls.
Study design
Single Centre Cohort study.
Study burden and risks
Participants will be asked for one blood sample of 60mL, drawn by peripheral
venous puncture at the Pulmonary Medicine laboratory or outpatient clinic.
Also, patients are asked to undergo a nasal brush. Furthermore, data on sex,
age, smoking- and relevant medical history are recorded. Risks of participation
are negligible, as these procedures are minimally invasive and safe. Healthy
volunteers will not have any personal benefit from participating but help
increase scientific knowledge on respiratory diseases in general. Participating
is completely voluntary, not participating in research will not influence the
way employees or patients and their accompanying partners are treated in any
way.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Age >= 18 years old
- not included in ongoing clinical studies
- Signed informed-consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- refusal of participation
- known respiratory or autoimmune disease
- treatment with immune suppression
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80535.078.22 |