Determining reference values for lymphocyte subpopulations in children
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
referentiewaarden bepaling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Absolute and relative numbers of T-lymphocytes, B-lymphocytes, NK-cells,
helper-T- and cytotoxic-T-lymphocytes, as well as absolute and relative numbers
of naïve B-lymphocytes, IgM-memory B-lymphocytes, switched-memory
B-lymphocytes, naïve and effector helper-T and cytotoxic-T-lymphocytes and
central or effector memory helper-T and cytotoxic-T lymphocytes.
Secondary outcome
-
Background summary
Summary of the study: Age-matched reference values for lymphocyte
subpopulations in children
Immunophenotyping is an important tool in the diagnosis of immunological and
haematological diseases. Age-matched reference values have been determined for
the major lymphocyte populations (B-, T-, helper-T- and cytotoxic-T-lymphocytes
and NK-cells), but are unavailable at present for subpopulations like naïve and
memory cells, which are of special interest in a maturing immune system. Also,
in specific immunological diseases immunophenotyping results are used for
categorisation of patients and sometimes even for prognostic estimates.
For this study we are determining reference values for B- and T-lymphocyte
subpopulations. Therefore we include healthy patients in different age groups.
EDTA-blood of these patients will be used for immunophenotyping with monoclonal
antibodies by flowcytometry. We will determine absolute and relative numbers of
T-lymphocytes, B-lymphocytes, NK-cells, helper-T- and cytotoxic-T-lymphocytes.
As well as absolute and relative numbers of naïve B-lymphocytes, IgM-memory
B-lymphocytes, switched-memory B-lymphocytes, naïve and effector helper-T and
cytotoxic-T-lymphocytes and central or effector memory helper-T and cytotoxic-T
lymphocytes.
Summary of amendment 1
The monoclonal antibodies used in this study are adjusted for recent literature
at actual start of the study.
Summary of amendment 2
Because it is difficult to include enough patients below two years of age, we
will ask parents permission for a sole venapuncture, or a blood sample from
heel or finger. A maximum of 35 children will be included according to the
procedure described in this amendment.
Study objective
Determining reference values for lymphocyte subpopulations in children
Study design
Cross-sectional study design
Intervention
One venapuncture or blood sample taken from the heel or finger.
Study burden and risks
A sole venapuncture or bloodsample taken from the heel or vinger in healthy
children under 2 years of age after permission of the parents. The risks are
minimal: maximum a bruise.
Postbus 90153
5200 ME 's-Hertogenbosch
NL
Postbus 90153
5200 ME 's-Hertogenbosch
NL
Listed location countries
Age
Inclusion criteria
Healthy children under the age of two years
Exclusion criteria
- Ill or recent infection (last two weeks)
- Immunomodulating or suppressive therapy
- Immunological diseases
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 | NL28948.000.09 |