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Monitoring Risks for Hematological Changes in Gas Station Workers

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05135078
Collaborator
(none)
50
Enrollment
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Monitoring Risks for Hematological Changes in Gas Station Workers
    Anticipated Study Start Date :
    Dec 1, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. The aim of study is to evaluate and monitor risks for hematological changes in gas station workers [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 .

    2. The aim of study is to evaluate and monitor risks for hematological changes in gas station workers [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.

    3. The aim of study is to evaluate and monitor risks for hematological changes in gas station workers [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 .

    4. The aim of study is to evaluate and monitor risks for hematological changes in gas station workers [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

    5. The aim of study is to evaluate and monitor risks for hematological changes in gas station workers [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 .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    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 .

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sara Talaat Taha, Principal investigator ., Sohag University
    ClinicalTrials.gov Identifier:
    NCT05135078
    Other Study ID Numbers:
    • Soh-Med-21-10-08
    First Posted:
    Nov 26, 2021
    Last Update Posted:
    Nov 26, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hematologic Diseases

    Study Results

    No Results Posted as of Nov 26, 2021