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Assessment of DNA Damage Due to Ionizing Radiation

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ClinicalTrials.gov Identifier: NCT03240172
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
asmaa mohamed, Assiut University

Brief 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.

Condition or disease
Occupational Exposure

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Assessment of DNA Damage and Capacity of DNA Repair System Among Nuclear Medicine and Clinical Oncology Workers Exposing to Ionizing Radiation
Actual Study Start Date : July 20, 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. detection of DNA damage due to occupational exposure to ionizing radiation [ Time Frame: 6 month ]
    comet assay technique will be used



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
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,.

Criteria

Inclusion Criteria:

  • • The radiation exposed workers will include nurses, technicians and physicians.

These persons will be occupationally exposed to different radiation sources.

Exclusion Criteria:

  • History of diagnostic X-rays, radiotherapy and/or chemotherapy 12 months prior to sampling.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240172


Contacts
Contact: asmaa HA mohamed, PHD 01027029243 asmaahasan@aun.edu.eg
Contact: amal RA ibrahim, lecturer 010022454482 amal3774rayan@gmail.com

Locations
Egypt
Assiut university Recruiting
Assiut, Egypt, 71511
Contact: amal RA Ibrahim, lecturer    002010022454482    amal3774rayan@gmail.com   
Contact: aml AL mohamed, lecturer    002010016353580    aml_aly@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: asmaa HA mohamed, PHD Assiut University

Responsible Party: asmaa mohamed, Director, clinical research, Assiut University
ClinicalTrials.gov Identifier: NCT03240172     History of Changes
Other Study ID Numbers: 17200101
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017