In this study we would like to find new biomarkers in BOS after haematopoietic stem cell transplantation (HSCT), that may lead to earlier identification of BOS than a lung function decline.
ID
Source
Brief title
Condition
- Other condition
- Respiratory disorders NEC
Synonym
Health condition
afstoting na beenmergtransplantatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Identifying biomarkers in the peripheral blood that predict BOS by a sgnificant
elevation before a lungfunction decline occurs (i.e. a drop in FEV1 of 20%)
after allogeneic hemtopoietic stem cell transplantation.
.
Secondary outcome
To determine the incidence and outcome of allo-reactive lung syndromes (i.e.
BOS and other ARLS) in patients that underwent allogeneic haematopoietic stem
cell transplantation.
Background summary
Graft versus host disease after allogeneic hemtopoietic stem cell
transplantation (HSCT) may cause allo-reactive lung syndromes (ARLS) and
especially bronchiolitis obliterans syndrome (BOS). In its clinical and
histological appearance it closely resembles the bronchiolitis obliterans
syndrome that occurs in patients after lung transplantation due to chronic
rejection. In previous studies we have described specific biomarkers for the
bronchiolitis obliterans syndrome after lung transplantation.
Study objective
In this study we would like to find new biomarkers in BOS after haematopoietic
stem cell transplantation (HSCT), that may lead to earlier identification of
BOS than a lung function decline.
Study design
All patients that have been selected for allogeneic HSCT at the UMC Utrecht
will be included and followed for 3 years. Spirometry, and blood samples will
be performed before and after stem cell transplantation. Blood samples will be
drawn to investigate biomarkers that may be predict BOS earlier than a drop of
20 % in forced expiratory volume in one second measuresd by spirometry which is
the current standard to diagnose BOS .
We will use biomarkers we have used in BOS after lung transplantation and by
using Luminex assays we will search for new biomarkers in the peripheral blood
Study burden and risks
Selection criteria of patients for allogeneic hemtopoietic stem cell
transplantation (HSCT) are not dependent on our study. This study does not
intervene with the indication for HSCT or treatment of HSCT patients. There are
no additional risks for these patients. Additional blood samples are taken with
known very low acceptable risks like haematoma or local pain during blood
sampling. When the hemoglobin value decreases below 5 mmol/L no additional
blood will be drawn. Lung function measurements have no additonal risk but may
be tiresome.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
Patients whom are selected for hematopoietic stem cell transplantation
Exclusion criteria
no informed consent
all patients after hematopoietic stem cell transplantation will be included except patients that do not want to participate in this study.
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 | NL38645.041.11 |