Monitoring Risks for Hematological Changes in Gas Station Workers

November 13, 2021 updated by: Sara Talaat Taha, Sohag University
Gas station workers are exposed to carcinogenic substances.This increases risk of their exposure to hematological diseases such as lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), myelodysplastic syndromes (MDS), and myelogenous leukemia (AML), as well as different forms of non-Hodgkin's lymphoma (NHL) and multiple myeloma. Thus, the early identification of this condition between the gas station workers may prevent the hematological disease progression.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Gas station workers are exposed to carcinogenic substances.This increases risk of their exposure to hematological diseases such as lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), myelodysplastic syndromes (MDS), and myelogenous leukemia (AML), as well as different forms of non-Hodgkin's lymphoma (NHL) and multiple myeloma.

It is known that severe bone marrow dysplasia is frequently accompanied by early alterations in the immune system and in peripheral cell subsets.

The bone marrow injury by benzene metabolites is a strong predisposing factor in the pathogenesis of Benzene-induced hematopoietic disease .Thus, the early identification of this condition between the gas station workers may prevent the hematological disease progression.

The reactive metabolite of benzene, 1,4-benzoquinone (BQ) is suggested to be a key molecule of benzene-induced hematotoxicity and carcinogenicity as it cause abnormal accumulation of myeloid cells and precursors, which cause benzene induced cytopenia and myeloid dysplasia in humans.

Study Type

Observational

Enrollment (Anticipated)

50

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

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

gas station workers exposed to benzene more than 3 years

Description

Inclusion Criteria:

  • This study will be conducted on a group of gas station workers exposed to benzene for more than 3 years .

Exclusion Criteria:

  • diagnosed gas station workers with blood malignancies .
  • gas station workers exposed to benzene for less than 3 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

Outcome Measure
Measure Description
Time Frame
The aim of study is to evaluate and monitor risks for hematological changes in gas station workers
Time Frame: within 6 months .
The study will be conducted to a group of gas station workers exposed to benzene for more than 3 years, All workers will be subjected to complete blood count .
within 6 months .
The aim of study is to evaluate and monitor risks for hematological changes in gas station workers
Time Frame: within 6 months .
The study will be conducted to a group of gas station workers exposed to benzene for more than 3 years, All workers will be subjected to liver function tests as alanine transaminase (ALT) measured by IU/L, aspartate transaminase (AST) measured by IU/L, total protein measured by gm/dl, albumin measured by g/dl and bilirubin measured by mg/dl.
within 6 months .
The aim of study is to evaluate and monitor risks for hematological changes in gas station workers
Time Frame: within 6 months .
The study will be conducted to a group of gas station workers exposed to benzene for more than 3 years, All workers will be subjected to renal function tests as serum creatinine measured by mg/dl, serum urea measured by mg/dl and uric acid measured by mg/dl .
within 6 months .
The aim of study is to evaluate and monitor risks for hematological changes in gas station workers
Time Frame: within 6 months .
The study will be conducted to a group of gas station workers exposed to benzene for more than 3 years, All workers will be subjected to CD45, CD34, HLA-DR, CD33, CD13, CD19, CD22, CD2, CD3, CD5, CD7, CD4, CD8, CD10, CD16 and CD65 measured by flowcytometry
within 6 months .
The aim of study is to evaluate and monitor risks for hematological changes in gas station workers
Time Frame: within 6 months ,
The study will be conducted to a group of gas station workers exposed to benzene for more than 3 years, All workers will be subjected to ESR (Erythrocyte sedimentation rate) measured by mm .
within 6 months ,

Collaborators and Investigators

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

Sponsor

Sohag University

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)

December 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

November 13, 2021

First Posted (ACTUAL)

November 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-10-08

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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