Prognostic Role of Platelet _lymphocyte and Neutrophil _monocyte in CLL

March 22, 2021 updated by: Fatma Hussein Mahmoud, Assiut University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All Patients with CLL come to South Egypt Cancer institute from 2010 to 2020

Description

Inclusion Criteria:

- All CLL patients

Exclusion Criteria:

  • CLL patients on treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
platelet-lymphocyte and neutrophilo_monocyte ratio in CLL
Time Frame: base line
Calculating the ratio of platelets to lymphocytes and neutrophils to monocytes in CLL cases
base line

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Prognostic factors in CLL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings