Hematologic DiseasesNCT05135078
Monitoring Risks for Hematological Changes in Gas Station Workers
An observational study of Hematologic Diseases, run by Sohag University.
Trial 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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Hematologic Diseases
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Child, Adult, Older adult
Study population: gas station workers exposed to benzene more than 3 years
Who may be able to join
- This study will be conducted on a group of gas station workers exposed to benzene for more than 3 years .
Who cannot join
- diagnosed gas station workers with blood malignancies .
- gas station workers exposed to benzene for less than 3 years .
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Hematologic Diseases
- Medical subject headings
- Hematologic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of study is to evaluate and monitor risks for hematological changes in gas station workers
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 .
Measured: within 6 months .
The aim of study is to evaluate and monitor risks for hematological changes in gas station workers
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.
Measured: within 6 months .
The aim of study is to evaluate and monitor risks for hematological changes in gas station workers
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 .
Measured: within 6 months .
The aim of study is to evaluate and monitor risks for hematological changes in gas station workers
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
Measured: within 6 months .
The aim of study is to evaluate and monitor risks for hematological changes in gas station workers
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 .
Measured: within 6 months ,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Talaat Taha, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135078
- Sponsor's protocol ID
- Soh-Med-21-10-08
- Status last verified
- Oct 2021
- First submitted
- 14 Oct 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Risks for Hematological Changes in Gas Station Workers
- ClinicalTrials.gov ID
- NCT05135078
- Acronym / sponsor ID
- Soh-Med-21-10-08
- Conditions
- Hematologic Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- gas station workers exposed to benzene more than 3 years
Key inclusion criteria (1 listed)
- This study will be conducted on a group of gas station workers exposed to benzene for more than 3 years .
Key exclusion criteria (2 listed)
- diagnosed gas station workers with blood malignancies .
- gas station workers exposed to benzene for less than 3 years .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 .
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.
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 .
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
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 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Diseases, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara T taha (01020858495, sara011097@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The aim of study is to evaluate and monitor risks for hematological changes in gas station workers (time frame: within 6 months .). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.