To investigate the clinical and biological characteristics of MBL in order to obtain insight into CLL leukemogenesis and disease progression.
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Characterisation of cell surface markers of MBL patients compared to an
age-matched control group from general population and to CLL patients.
- Gene expression levels of MBL patients compared to normal B-lymphocytes and
to CLL patients.
Secondary outcome
- Descriptive analysis of incidence of infections and antibiotics usage in
patients with MBL.
- Characterisation of cell surface markers of non-progressive MBL patients
versus progressive MBL patients
- Characterisation of gene expression levels of non-progressive MBL patients
versus progressive MBL patients.
Background summary
Monoclonal B-cell Lymphocytosis (MBL) is a relatively new and asymptomatic
entity wherein small B cell clones, with a typical Chronic Lymphocytic
Leukaemia (CLL)-immunophenotype, are detectable in the peripheral blood. MBL
has been shown to be a precursor state for CLL, 15% will develop progressive
CLL, 7% eventually require chemotherapy and 2% will die as a result of
progressive disease. Since MBL and CLL are characterised by an extremely
heterogeneous clinical course, ranging from an indolent disease without
progression towards progressive disease requiring treatment and possibly death,
prognostic markers which can reliably predict the course of the disease at
diagnosis are warranted. MBL is of interest to investigate clinical and
biological characteristics to better understand the mechanisms of CLL
leukemogenesis by identifying factors that are either shared or divergent
between MBL and CLL. These clinical and biological characteristics will not
only provide inside into the pathophysiology of the disease but also give
important information about the prognosis and might enable more sophisticated
and individualized new therapeutic strategies.
Study objective
To investigate the clinical and biological characteristics of MBL in order to
obtain insight into CLL leukemogenesis and disease progression.
Study design
The study is an observational study in which patients need to visit the
hospital once to let drawn blood to investigate T-cell subsets and expression
levels of apoptosis genes.
Study burden and risks
The risks are low and patients have a minimum of discomfort. Patients only have
to visit the hospital once to let drawn blood. This procedure does not
interfere with standard medical care and this study will give more insight in
CLL leukomegenesis which might benefit CLL patients in future.
Koekoekslaan 1
3435 CM Nieuwegein
Nederland
Koekoekslaan 1
3435 CM Nieuwegein
Nederland
Listed location countries
Age
Inclusion criteria
All patients over the age of 18 years who were diagnosed with MBL or CLL ever since March 2001 are eligible for the study.
Exclusion criteria
Psychiatric disease or inability to give informed consent
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 | NL34627.100.10 |