Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04811950 |
| Other study ID # |
Prognostic factors in CLL |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2022 |
| Est. completion date |
October 2023 |
Study information
| Verified date |
March 2021 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The biological rationale in calculating PLR stems from the increase in the lymphocyte count
and reduction in the platelet count often encountered in the advances stages of CLL .NMR
median value was significantly higher in untreated patients than in patients who received
treatment strengthening the hypothesis that this ratio is associated with a more indolent
form of disease
Description:
Chronic lymphocytic leukemia (CLL) is the most common type of leukemia in the western world.
In Egypt, CLL is the most common subtype of leukemias
- the National Cancer Registry reported over 80% of lymphoid leukemias are CLL . It is the
most common types of leukemia diagnosed in adult.
ChroniclymphocyticleukemialymphocytesareclonalCD19-positiveBcells characterized by the
accumulation of CD5 positive monoclonal B cells in peripheral blood. Bone marrow
aspiration shows lymphocytic replacement of normal marrow elements, lymphocytes comprise
25-95% .Trephine biopsy reveals nodular, diffuse or interstitial involvement by
lymphocytes
- Both the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) and European
Society of Medical Oncology guidelines also require persistence of lymphocytosis for
longer than 3 months
The most important prognostic factors in CLL are clinical staging systems developed by Rai
and Binet
. These systems based on clinical examination e.g. lymphadenopathy and organomegaly,
peripheral blood findings (platelet
andhaemoglobinvalues),markersoftumorload(thymidinekinaseand B2-microglobulin), expression of
specific proteins in CLL cells; CD38, CD49d & ZAP-70, genetic abnormalities quantified by
FISH which include del(13q), tri12, del(11q), & del(17p) and genetic parameters.including
immunoglobulin heavy chain variable gene segment (IGHV) mutational status. Finally,
prognostication in patients with CLL should not only address disease progression and overall
survival, but also response to therapy. The biological rationale in calculating PLR stems
from the increase in the lymphocyte count and reduction in the platelet count often
encountered in the advanced stages of CLL. Therefore, we hypothesized that the ratio using
both the platelet and lymphocyte counts may have a prognostic role in patients with CLL.
Neutrophil-monocyte ratio(NMR) was found to be higher in untreated patients than in patients
who received treatment . and therefore it will be used to prove its relation with disease
severity and itsprognosticvalues. It is important to highlight that using these indices, is
simple, cheap, easily measured and reproducible and can be integrated into our daily clinical
practice as prognostic marker of CLL
