The primary objective is to investigate if there are differences in BTK and B cell receptor signaling (measure for B cell activation) in patients with and without repetitive episodes of ACR. This endpoint will be constituted from peripheral blood…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
afstoting long transplantaat
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- BTK protein expression in peripheral B cells. (flow cytometry).
- BCR signalling, measured by increased phosphorylation of pSYK in in vitro
stimulated B cells compared to unstimulated B cells. (culture and phosphoflow)
Secondary outcome
- To assess the T cell phenotype and activation
- To assess the NK cell phenotype and activation
- To measure the cytokine production by T cells
- To determine Nuclear Factor kappa-B (NFkB) signaling in primary T cell
subsets by means of flow cytometry.
- Correlation of the findings in previously obtained peripheral lung
biopsies; in order to
clinico-pathologically correlate this with the findings of the immune cell
subsets
by means of immunohistochemistry (IHC).
Background summary
After lung transplantation there are recipients who encounter episodes of acute
cellular rejection (ACR) and there are recipients who do not encounter these
episodes at all. We hypothesize that specific differences in immune
constitution and their response can explain this difference. By detection and
confirmation of these differences, allograft reactivity could be predicted and
subsequent treatment can be altered to prevent recipients from developing one
or more episodes of allograft reactivity.
Study objective
The primary objective is to investigate if there are differences in BTK and B
cell receptor signaling (measure for B cell activation) in patients with and
without repetitive episodes of ACR. This endpoint will be constituted from
peripheral blood withdrawn from patients after lung transplantation.
Study design
case-control study
Study burden and risks
Peripheral blood will be withdrawn once, after informed consent, by means of
vena puncture during routine outpatient visit. Vena puncture can cause mild
discomfort; the puncture could be experienced as being painful, and a hematoma
could result from this procedure. There are no further risks associated with
participation. The subject will not have direct benefit from the findings in
this study, but it could be of great value for optimizing post-lung
transplantation care and prevention and management of allograft reactivity.
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:
1. Patients (18-70 years) who underwent uni- or bilateral lung transplantation.
AND
2. Written informed consent.
AND
3. One or more episodes of acute cellular rejection within the first two years
after lung transplantation
OR
4. No episode of acute cellular rejection within the first two years after lung
transplantation.
Exclusion criteria
1. Non-compliance to treatment
2. Active or treated malignancy (solid or hematological malignancies).
3. Who underwent a lung retransplantation.
4. Repetitive episodes of infection in advance of an episode of acute cellular
rejection
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 | NL73594.078.20 |