Systemic Inflammatory Markers in B-cell Neoplasm

March 9, 2025 updated by: Marline Wiliam Fayez Abdel-Shahid, Assiut University

Systemic Inflammatory Markers As a Prognostic Index for B-cell Neoplasm , Single Center Experience .

This study was to evaluate the role of systemic inflammatory markers in predicting outcome for patients with B cell neoplasm

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.

Detailed Description

In malignant tumors, Inflammation plays a crucial role in the development, invasion, and metastasis of malignant tumors. Cancer is often described as a wound that does not heal, highlighting the significance of inflammation in cancer progression. Many tumors are heavily infiltrated by immune cells, including macrophages, neutrophils, and lymphocytes. Therefore, markers related to inflammation and the host immune response are pertinent as biological indicators of B-cell neoplasm progression. Inflammation contributes significantly to the initiation and advancement of B-cell neoplasms by providing nutrients to tumor cells, promoting cell growth, and disrupting immune homeostasis. Various composite indices based on circulating inflammatory cells have been developed as straightforward measures to assess systemic inflammation. Elevated serum inflammatory markers reflect the body's response to malignant tumors. Pro-inflammatory cytokines and inflammatory cells within the tumor microenvironment have been shown to promote tumor growth, induce DNA damage, facilitate angiogenesis, suppress the immune system, and correlate with poor patient survival outcomes. Targeting cytokine receptors or other components in inflammatory pathways involved in metastasis may offer therapeutic potential for malignant tumors. Given the pivotal role of inflammation in cancer biology, identifying novel immune markers is essential for predicting the prognosis of patients with Diffuse Large B-Cell Lymphoma (DLBCL). patients

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 (Estimated)

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.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

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

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Based on determining the main outcome variable, the estimated minimum required sample size is 74. The sample size was calculated using G*power software 3.1.9.4 , based on the following assumptions: Main outcome variable is the evaluation of role of systemic inflammatory markers in predicting outcome for patients with B cell neoplasm. Based on expert opinion we hypothesized to find medium effect size 0.3

Description

Inclusion Criteria:

  • Individuals newly diagnosed with B-cell neoplasms, including:
  • Burkitt's lymphoma (BL)
  • Chronic lymphocytic leukemia (CLL)
  • Diffuse large B-cell lymphoma (DLBCL)
  • Follicular lymphoma (FL)
  • Hairy cell leukemia (HCL)
  • Splenic B-cell lymphoma/leukemia with prominent nucleoli (SBLPN)
  • High-grade B-cell lymphoma (HGBL)
  • Lymphoplasmacytic lymphoma (LPL)/Waldenström macroglobulinemia
  • Mantle cell lymphoma (MCL)
  • Splenic marginal zone lymphoma (MZL)
  • Monoclonal B-cell lymphocytosis (MBL)
  • Multiple myeloma (plasma cell myeloma)
  • Monoclonal gammopathy of undetermined significance (MGUS)
  • Age 18 years or older.

Exclusion Criteria:

  • Individuals previously diagnosed with B-cell neoplasms.
  • Individuals younger than 18 years.

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
Determination of Optimal Cut-off Values for Systemic Inflammatory Indices in B-cell Neoplasms Using Laboratory Blood Tests
Time Frame: Baseline
This outcome measure aims to establish the optimal cut-off values for systemic inflammatory indices-including Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), and Lymphocyte-to-Monocyte Ratio (LMR)-using routine laboratory blood tests. The blood tests will include serum lactate dehydrogenase (LDH), globulin, albumin, C-reactive protein (CRP), platelet count, neutrophil count, lymphocyte count, and monocyte count. Receiver Operating Characteristic (ROC) curve analysis will be employed to determine the optimal cut-off values for each inflammatory marker.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prognostic Value of Baseline Systemic Inflammatory Markers on Overall Survival in B-cell Neoplasm Patients
Time Frame: From baseline up to 8 months
This outcome measure evaluates the association between baseline systemic inflammatory markers and overall survival in patients with B-cell neoplasms. The markers to be assessed include serum levels of LDH, globulin, albumin, CRP, and blood cell counts (neutrophils, lymphocytes, monocytes). Additionally, calculated indices such as NLR, PLR, LMR, CRP-to-Albumin Ratio (CAR), Albumin-to-Globulin Ratio (AGR), Systemic Immune-Inflammation Index (SII), and Systemic Inflammation Response Index (SIRI) will be determined. Patient follow-up will be conducted for 6 to 8 months or until the completion of the chemotherapeutic regimen or death.
From baseline up to 8 months

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Alaa El-Din Abdel Moneim El-Sayed, Doctor, 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 (Estimated)

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.
March 22, 2025

Primary Completion (Estimated)

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.
November 30, 2025

Study Completion (Estimated)

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.
December 30, 2025

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).
February 21, 2025

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.
February 21, 2025

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 25, 2025

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 25, 2025

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 9, 2025

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, 2025

More Information

Terms related to this study

Keywords

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.
  • markers In B-cell tumors

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

product manufactured in and exported from the U.S.

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