NCT03240172

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

August 2, 2017

Last Update Submit

August 15, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • detection of DNA damage due to occupational exposure to ionizing radiation

    comet assay technique will be used

    6 month

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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,.

You may qualify if:

  • The radiation exposed workers will include nurses, technicians and physicians.
  • These persons will be occupationally exposed to different radiation sources.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71511, Egypt

RECRUITING

Study Officials

  • asmaa HA mohamed, PHD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

asmaa HA mohamed, PHD

CONTACT

amal RA ibrahim, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, clinical research

Study Record Dates

First Submitted

August 2, 2017

First Posted

August 7, 2017

Study Start

July 20, 2016

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

August 17, 2017

Record last verified: 2017-08

Locations