Assessment of DNA Damage Due to Ionizing Radiation | NCT03240172

Studies
Assessment of DNA Damage Due to Ionizing Radiation

NCT03240172

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Aug 17, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Occupational Exposure

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2016Actual

Primary Completion Date

Jul 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Aug 2, 2017

First Submission Date that Met QC Criteria

Aug 2, 2017

First Posted Date

Aug 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2017

Last Update Posted Date

Aug 17, 2017Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
detection of DNA damage due to occupational exposure to ionizing radiation	comet assay technique will be used	6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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,.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
asmaa HA mohamed, PHD	Contact	01027029243		asmaahasan@aun.edu.eg
amal RA ibrahim, lecturer	Contact	010022454482		amal3774rayan@gmail.com

Overall Officials

Name	Affiliation	Role
asmaa HA mohamed, PHD	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university	Recruiting	Asyut		71511	Egypt