NCT01518673

Brief Summary

Patients undergoing a computed tomography are exposed to a relatively high dose of X-rays. Pediatric patients are known to be very radiosensitive with respect to radiation induced cancer. Using the technique of scoring γ-H2AX foci in peripheral blood lymphocytes the most important lesions to the genetic material DNA, double strand breaks induced by CT X-rays can be detected. The technique will be applied in a multicenter setting for evaluation of X-effects induced by a computed tomography examination in a population of pediatric patients. To this end a blood sample will be taken from the patients before and after the examination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

2.9 years

First QC Date

January 20, 2012

Last Update Submit

November 18, 2021

Conditions

Pediatric Patients Undergoing a Computed Tomography Examination

Outcome Measures

Primary Outcomes (1)

  • X-ray induced genetic effects in pediatric patients directly after a computed tomography scan.

    Assessment of γ -H2AX foci in peripheral blood lymphocytes.

    Within 30 min after the computed tomography examination.

Study Arms (1)

X-rays

Procedure: Blood test

Interventions

Blood testPROCEDURE

Analysing X-ray induced genetic effects in pediatric patients directly after a computer tomography scan.

X-rays

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients undergoing computed tomography are exposed to a relatively high dose of X-rays.

You may qualify if:

  • pediatric patients wearing a catheter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood lymphocytes

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Peter Smeets, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2012

First Posted

January 26, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2015

Study Completion

June 1, 2015

Last Updated

November 19, 2021

Record last verified: 2021-11

Locations

BE(1)