Pediatric Patients Undergoing a Computed Tomography ExaminationPedCTBeNCT01518673
Low Dose Effects of X-rays in Pediatric Patients Undergoing a CT Examination.
An observational study of Pediatric Patients Undergoing a Computed Tomography Examination, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Pediatric Patients Undergoing a Computed Tomography Examination
- What is being tested?
- Blood test
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2012to Jun 2015
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients undergoing computed tomography are exposed to a relatively high dose of X-rays.
Who may be able to join
- pediatric patients wearing a catheter
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Study of Low Dose Effects of X-rays in Pediatric Patients Undergoing a CT Examination.
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.
- Being tested
- Blood test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testProcedure or surgery
Analysing X-ray induced genetic effects in pediatric patients directly after a computer tomography scan.
| Study group | Role | What they receive |
|---|---|---|
| X-rays | Not described Receives: Procedure: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
X-ray induced genetic effects in pediatric patients directly after a computed tomography scan.
Assessment of γ -H2AX foci in peripheral blood lymphocytes.
Measured: Within 30 min after the computed tomography examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Patients Undergoing a Computed Tomography ExaminationStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Agency for Nuclear Control, Belgium
- Responsible party
- Sponsor
- Investigators
- Peter Smeets, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518673
- Sponsor's protocol ID
- 2010/708
- Acronym
- PedCTBe
- Status last verified
- Nov 2021
- First submitted
- 20 Jan 2012
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Study of Low Dose Effects of X-rays in Pediatric Patients Undergoing a CT Examination.
- ClinicalTrials.gov ID
- NCT01518673
- Acronym / sponsor ID
- PedCTBe / 2010/708
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Federal Agency for Nuclear Control, Belgium
- Study start
- Feb 2012 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Jan 2012 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| X-rays | – | Procedure: Blood test |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients undergoing computed tomography are exposed to a relatively high dose of X-rays.
Key inclusion criteria (1 listed)
- pediatric patients wearing a catheter
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testAnalysing X-ray induced genetic effects in pediatric patients directly after a computer tomography scan. | Procedure or surgery | X-rays |
Primary outcome
X-ray induced genetic effects in pediatric patients directly after a computed tomography scan.
Time frame: Within 30 min after the computed tomography examination.
Assessment of γ -H2AX foci in peripheral blood lymphocytes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Related InfoLink provided by the sponsor.
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.
Peter Smeets, MD principal investigator
University Hospital, Ghent
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 Pediatric Patients Undergoing a Computed Tomography Examination, run by University Ghent at 1 site in Belgium.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 19 Nov 2021. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
X-ray induced genetic effects in pediatric patients directly after a computed tomography scan. (time frame: Within 30 min after the computed tomography examination.). 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 19 Nov 2021.