Prognostic Role of Platelet _lymphocyte and Neutrophil _monocyte in CLL

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04811950

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
CLL Progression	Device: Emerald

Detailed 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

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Assessment of Prognostic Role of Platelet-lymphocyte and Neutrophil _monocyte Ratio in CLL

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Oct 1, 2023

Outcome Measures

Primary Outcome Measures

platelet-lymphocyte and neutrophilo_monocyte ratio in CLL [base line]
Calculating the ratio of platelets to lymphocytes and neutrophils to monocytes in CLL cases

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All CLL patients

Exclusion Criteria:

CLL patients on treatment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Yu H, Xu W, Shen QD. [Serum levels of soluble CD(23) and thrombopoietin in chronic lymphocytic leukemia]. Zhonghua Nei Ke Za Zhi. 2008 Oct;47(10):826-9. Chinese.

Responsible Party:

Fatma Hussein Mahmoud, Principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT04811950

Other Study ID Numbers:

Prognostic factors in CLL

First Posted:

Mar 23, 2021

Last Update Posted:

Mar 23, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Disease Progression

Study Results

No Results Posted as of Mar 23, 2021