Overall objective of this IDeAL study is to unravel the biological heterogeneity of LGL leukemia and to correlate this with the clinical features. More specific objectives are: 1. Build a LGL leukemia registry (clinical features and lab data).2. Set…
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Observational study without formal endpoints. At the end of this study, more
insights will be gained about the following parameters:
• fenotypical features
• clonal TCR repertoire at DNA / RNA and possibly functional level
• (epi)genetic and transcriptional patterns
• (auto)antibodies and cytokines
Secondary outcome
NA
Background summary
LGL leukemia is a rare form of leukemia and is heterogeneous in course and
clinical presentation. The etiology and pathophysiology is largely unknown;
therefore better understanding of the mechanisms that cause survival of the LGL
cells is necessary. Therefore we have the intention in this study to start a
LGL registry to get more insight in the clinical characteristics and biological
mechanisms of LGL leukemia, which will eventually lead to newer and better
therapeutic options.
Study objective
Overall objective of this IDeAL study is to unravel the biological
heterogeneity of LGL leukemia and to correlate this with the clinical features.
More specific objectives are:
1. Build a LGL leukemia registry (clinical features and lab data).
2. Set up LGL leukemia biobank (blood cells, DNA / RNA, plasma).
3. Determine LGL leukemia fenotype compared to normal T-/NK- cells (and
subtypes) in healthy elderly.
4. Determine the clonal TCR repertoire of T-LGL leukemia compared to the TCR
repertoire in healthy elderly and evaluate the significance of TCR signaling.
5. Determination of (epi)genetic and transcriptional changes that discriminate
LGL leukemic cells from their normal counterparts.
6. Evaluation of biomarkers in cells and/of plasma in LGL leukemia.
Study design
Prospective observational study
Study burden and risks
There is a minimal extent of burden for the patients and risks are negligible.
With this study we aim to get insight about the biological mechanisms of LGL
leukemia, which will eventually lead to newer and better therapeutic options.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Patients with LGL leukemia / lymphoproliferation
Exclusion criteria
No 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 | NL65165.078.18 |