Radiation InjuryNCT00745641
Abdominal Computed Tomography and the Blood Reactive Oxygen Species Level
An observational study of Radiation Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The clinically widely used X-ray computed tomography examination has a low-grade radiation effect and recently has attracted much attention concerning the possible adverse effects of radiation on human body [ref. 1-5]. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Radiation Injury
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2008to Dec 2008
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with abdominal illness that needs a computed tomography examination
Who may be able to join
- patients with abdominal illness that needs a computed tomography examination
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Abdominal X-ray Computed Tomography Examination on the Blood Reactive Oxygen Species Level
The clinically widely used X-ray computed tomography examination has a low-grade radiation effect and recently has attracted much attention concerning the possible adverse effects of radiation on human body [ref. 1-5]. The radiation is harmful to human tissues and cells mainly because it can interact with water (which makes up to 80% of cells) to generate reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we can reach, there is no report concerning the relation between X-ray computed tomography examination and the blood ROS level. Therefore, we wish to conduct this study to clarify if the routinely applied abdominal X-ray computed tomography examination may induce a higher level of ROS in the peripheral blood.
Study subjects will be patients who are admitted to our hospital because of abdominal diseases that need to receive abdominal X-ray computed tomography examination for diagnosis. In total, sixty cases will be enrolled for the study. The formal consent will be delivered and explained to the patients and families several hours before the performance of abdominal X-ray computed tomography. The formal consent will be retrieved and then the peripheral blood will be sampled just before the performance of computed tomography.ROS level in the sampled peripheral blood, before and after the performance of abdominal X-ray computed tomography, will be measured, compared, and analyzed. Totally 120 blood samples, including 60 samples just before and 60 samples 2 hours after the performance of computed tomography, will be collected from 60 study subjects within 5 months (August 10 ~ December 30, 2008). Reactive oxygen species（ROS）levels will be measured by a chemiluminescence (CL) analysing system (CLD-110, Tohoku Electronic Industrial, Sendai, Japan).
- Conditions
- Radiation Injury
- Keywords
- radiation injury, computed tomography, reactive oxygen species, free radicals
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sixty patients with abdominal illness and scheduled abdominal X-ray computed tomography examination will be included. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Why it stopped: because of the presence of unexpected administrative barrier to interfere the collection of case
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Zei-Shung Huang, MD, PhD, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745641
- Sponsor's protocol ID
- 200807056R
- Status last verified
- Mar 2009
- First submitted
- 1 Sep 2008
- Last updated
- 7 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Abdominal X-ray Computed Tomography Examination on the Blood Reactive Oxygen Species Level
- ClinicalTrials.gov ID
- NCT00745641
- Acronym / sponsor ID
- 200807056R
- Conditions
- Radiation Injury
- Keywords
- radiation injury, computed tomography, reactive oxygen species, free radicals
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: because of the presence of unexpected administrative barrier to interfere the collection of case
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 3 Sep 2008 (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.
The clinically widely used X-ray computed tomography examination has a low-grade radiation effect and recently has attracted much attention concerning the possible adverse effects of radiation on human body [ref. 1-5]. The radiation is harmful to human tissues and cells mainly because it can interact with water (which makes up to 80% of cells) to generate reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we can reach, there is no report concerning the relation between X-ray computed tomography examination and the blood ROS level. Therefore, we wish to conduct this study to clarify if the routinely applied abdominal X-ray computed tomography examination may induce a higher level of ROS in the peripheral blood.
Study subjects will be patients who are admitted to our hospital because of abdominal diseases that need to receive abdominal X-ray computed tomography examination for diagnosis. In total, sixty cases will be enrolled for the study. The formal consent will be delivered and explained to the patients and families several hours before the performance of abdominal X-ray computed tomography. The formal consent will be retrieved and then the peripheral blood will be sampled just before the performance of computed tomography.ROS level in the sampled peripheral blood, before and after the performance of abdominal X-ray computed tomography, will be measured, compared, and analyzed. Totally 120 blood samples, including 60 samples just before and 60 samples 2 hours after the performance of computed tomography, will be collected from 60 study subjects within 5 months (August 10 ~ December 30, 2008). Reactive oxygen species（ROS）levels will be measured by a chemiluminescence (CL) analysing system (CLD-110, Tohoku Electronic Industrial, Sendai, Japan).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Sixty patients with abdominal illness and scheduled abdominal X-ray computed tomography examination will be included. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with abdominal illness that needs a computed tomography examination
Key inclusion criteria (1 listed)
- patients with abdominal illness that needs a computed tomography examination
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2009.
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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.
Zei-Shung Huang, MD, PhD principal investigator
NTUH
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 Radiation Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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: withdrawn, as of the sponsor's last update on 7 Aug 2009. 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 Taiwan. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 7 Aug 2009.