Occupational ExposureNCT03240172
Assessment of DNA Damage Due to Ionizing Radiation
An observational study of Occupational Exposure, run by Assiut University at 1 site in Egypt.
Trial summary
detection of DNA damage due to occupational exposure to low dose ionizing radiation using comet assay technique and genotyping of certain DNA repair genes to detect inherited polymorphism. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Occupational Exposure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2016to Dec 2018
- 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
- All sexes
- Child, Adult, Older adult
Study population: Case control study that will include 100 participants (50 radiation exposed workers will be compared with 50 healthy age and sex-matched control group not exposed to radiation. G power program was used to calculate the sample size for two independent groups. power calculation estimated to detect an effect size of 0.88 of difference between means of two independent groups, with a p value < 0.05 and 80% power,.
Who may be able to join
- • The radiation exposed workers will include nurses, technicians and physicians.
- These persons will be occupationally exposed to different radiation sources.
Who cannot join
- History of diagnostic X-rays, radiotherapy and/or chemotherapy 12 months prior to sampling.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university
Asyut, 71511
amal RA Ibrahim, lecturer, 002010022454482, amal3774rayan@gmail.com
aml AL mohamed, lecturer, 002010016353580, aml_aly@yahoo.com
About this study
Official title: Assessment of DNA Damage and Capacity of DNA Repair System Among Nuclear Medicine and Clinical Oncology Workers Exposing to Ionizing Radiation
detection of DNA damage due to occupational exposure to low dose ionizing radiation using comet assay technique and genotyping of certain DNA repair genes to detect inherited polymorphism.
- Conditions
- Occupational Exposure
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of DNA damage due to occupational exposure to ionizing radiation
comet assay technique will be used
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start20 Jul 2016
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational ExposureStudies of the same condition, open and under way.
- More trials run by Assiut 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-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, asmaa mohamed, Assiut University
- Investigators
- asmaa HA mohamed, PHD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240172
- Sponsor's protocol ID
- 17200101
- Status last verified
- Aug 2017
- First submitted
- 2 Aug 2017
- Last updated
- 17 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of DNA Damage and Capacity of DNA Repair System Among Nuclear Medicine and Clinical Oncology Workers Exposing to Ionizing Radiation
- ClinicalTrials.gov ID
- NCT03240172
- Acronym / sponsor ID
- 17200101
- Conditions
- Occupational Exposure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jul 2016 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Aug 2017 (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.
detection of DNA damage due to occupational exposure to low dose ionizing radiation using comet assay technique and genotyping of certain DNA repair genes to detect inherited polymorphism.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Case control study that will include 100 participants (50 radiation exposed workers will be compared with 50 healthy age and sex-matched control group not exposed to radiation. G power program was used to calculate the sample size for two independent groups. power calculation estimated to detect an effect size of 0.88 of difference between means of two independent groups, with a p value < 0.05 and 80% power,.
Key inclusion criteria (2 listed)
- • The radiation exposed workers will include nurses, technicians and physicians.
- These persons will be occupationally exposed to different radiation sources.
Key exclusion criteria (1 listed)
- History of diagnostic X-rays, radiotherapy and/or chemotherapy 12 months prior to sampling.
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
detection of DNA damage due to occupational exposure to ionizing radiation
Time frame: 6 month
comet assay technique will be used
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
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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.
asmaa HA mohamed, PHD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Exposure, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 1 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 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 asmaa HA mohamed, PHD (01027029243, asmaahasan@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of DNA damage due to occupational exposure to ionizing radiation (time frame: 6 month). 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 17 Aug 2017.