The Role of NK Cells to Detect Blood Infection in ALL.

November 29, 2023 updated by: Mostafa Sayed Mohamed Ahmed, Assiut University

The Role of Natural Killer Cell Profiling in Predictions of Blood Stream Infection and Antibiotic Resistance in Acute Lymphoblastic Leukemia Patients Post Chemotherapy.

  1. Assess possibility of prediction of blood stream infections in ALL patients by profiling of NK cells using flow cytometry.
  2. Assess the role of NK cells in development of drug resistance post chemotherapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Acute lymphoblastic leukemia (ALL) is the most common malignancy affecting children accounting for approximately 30% of childhood cancers (Zeng XL et al, 2023 ALL is characterized by chromosomal abnormalities and genetic alterations involved in the differentiation and proliferation of lymphoid precursor cells (Fujita, Sousa-Pereira et al. 2021).

ALL is categorized in B-Lymphoblastic Leukemia (B-ALL) And T-Lymphoblastic Leukemia (T-ALL), originated from B- and T-Lineage lymphoid precursor cells, respectively (Chiaretti S et al, 2014).

Recent progress in treatment of ALL has increased the survival rate significantly. The 5-year survival rate in children with ALL is approximately 90% (Paul 2016).

Bloodstream infection is a major cause of treatment-related morbidity and mortality in pediatric patients treated for acute lymphoblastic leukemia (Wolf, Tang et al. 2017).

This is caused by severe and prolonged immunosuppression due to neutropenia, and other chemotherapy-induced alterations of host defense mechanisms The rise of multidrug-resistant bacteria has generated a great challenge to treat infections caused by bacteria with the available antibiotics One of the crucial first line of defense against bloodstream infections in the immune system are Natural Killer cells Natural killer (NK) cells are lymphocytes of the innate immune system that are critical in host defense and immune regulation They can mediate spontaneous cytotoxicity towards malignant cells and microbes, and rapidly secrete numerous cytokines and chemokines to promote subsequent adaptive immune responses

NK cells can be subdivided into different populations based on the relative expression of the surface markers CD16 and CD56

Study Type

Observational

Enrollment (Estimated)

56

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

  • Name: Mostafa S Mohamed Ahmed, Resident
  • Phone Number: +20 1015277059
  • Email: nastrid50@gmail.com

Study Contact Backup

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Primary care clinic.

Description

Inclusion Criteria:

  • Patients aged less than 17 years diagnosed as Acute Lymphoblastic Leukemia and on chemotherapy, who are positive for blood stream infection.

Exclusion Criteria:

  1. Patients over 17 years of age.
  2. Presence of other hematological malignancies or history of other malignancies.

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

Outcome Measure
Measure Description
Time Frame
Number of participants who test positive for bloodstream infection and NK cells profile
Time Frame: Baseline
Assess the number of participants who are positive for bloodstream infection in microbial identification instrument, then comparison of Flow cytometry results for CD16 and CD56 to identify role of NK cells.
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Shaimaa G Mansour, Professor, South Egypt Cancer Institure, Assiut, Egypt
  • Study Chair: Eman M Abdel Rahman, Lecturer, 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)

February 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Estimated)

December 7, 2023

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK cells for infection in ALL

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.

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