HealthyNCT00712998
X-Ray Computed Tomography and Blood Reactive Oxygen Species Level
An observational study of Healthy, 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 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2008to Jul 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: participants of health check program at our hospital
Who may be able to join
- Participants of health check program at our hospital who will receive a scheduled X-ray computed tomography examination for either lung (20 cases) or heart (20 cases).
Who cannot join
- Those whose age are under 50 or above 70 year-olds will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of X-Ray Computed Tomography Examination on the Blood Reactive Oxygen Species Level in Apparently Healthy Adults
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 concentration. Therefore, we wish to conduct this study to clarify if the routinely applied X-ray computed tomography examination may induce a higher concentration of ROS in the peripheral blood.
Study subjects will be participants of health check program at our hospital. The only enrollment condition will be a scheduled X-ray computed tomography examination for either lung (20 cases) or heart (20 cases) of the study subject. Another 20 participants receiving health check program without X-ray computed tomography examination will be included as the control group. The formal consent will be delivered to the participants of health check program several days before their admission for health check and will be retrieved before the proceeding of health check.
Measurements and comparison of ROS concentration will be performed in the sampled peripheral blood before and after the performance of X-ray computed tomography examination during a regular health check program. Totally 120 blood samples will be collected from included 60 study subjects within 3 months. Reactive oxygen species（ROS）levels will be measured by a chemiluminescence (CL) analysing system (CLD-110, Tohoku Electronic Industrial, Sendai, Japan).
- Conditions
- Healthy
- Keywords
- radiation injuries, free radicals, reactive oxygen species, radiation injury from X-ray computed tomography, free radical production, blood reactive oxygen species level
- 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 | Twenty subjects receiving health check program without X-ray computed tomography examination will be included as the control group. | |
| 2 | Twenty subjects receiving health check program including X-ray computed tomography examination of lung will be included as the treatment group-1. | |
| 3 | Twenty subjects receiving health check program including X-ray computed tomography examination of heart will be included as the treatment group-2. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2008 (estimated)
- Study completionJul 2008 (estimated)
Why it stopped: Beacuse of unexpected administrative barriers, only 5 cases were enrolled in a year.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- NCT00712998
- Sponsor's protocol ID
- 200803085R
- Status last verified
- Mar 2008
- First submitted
- 9 Jul 2008
- Last updated
- 19 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of X-Ray Computed Tomography Examination on the Blood Reactive Oxygen Species Level in Apparently Healthy Adults
- ClinicalTrials.gov ID
- NCT00712998
- Acronym / sponsor ID
- 200803085R
- Conditions
- Healthy
- Keywords
- radiation injuries, free radicals, reactive oxygen species, radiation injury from X-ray computed tomography, free radical production, blood reactive oxygen species level
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Beacuse of unexpected administrative barriers, only 5 cases were enrolled in a year.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Jul 2008 (estimated)
- First posted
- 11 Jul 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 concentration. Therefore, we wish to conduct this study to clarify if the routinely applied X-ray computed tomography examination may induce a higher concentration of ROS in the peripheral blood.
Study subjects will be participants of health check program at our hospital. The only enrollment condition will be a scheduled X-ray computed tomography examination for either lung (20 cases) or heart (20 cases) of the study subject. Another 20 participants receiving health check program without X-ray computed tomography examination will be included as the control group. The formal consent will be delivered to the participants of health check program several days before their admission for health check and will be retrieved before the proceeding of health check.
Measurements and comparison of ROS concentration will be performed in the sampled peripheral blood before and after the performance of X-ray computed tomography examination during a regular health check program. Totally 120 blood samples will be collected from included 60 study subjects within 3 months. 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
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Twenty subjects receiving health check program without X-ray computed tomography examination will be included as the control group. |
| 2 | – | –Twenty subjects receiving health check program including X-ray computed tomography examination of lung will be included as the treatment group-1. |
| 3 | – | –Twenty subjects receiving health check program including X-ray computed tomography examination of heart will be included as the treatment group-2. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- participants of health check program at our hospital
Key inclusion criteria (1 listed)
- Participants of health check program at our hospital who will receive a scheduled X-ray computed tomography examination for either lung (20 cases) or heart (20 cases).
Key exclusion criteria (1 listed)
- Those whose age are under 50 or above 70 year-olds will be excluded.
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 stopped early (reason given: Beacuse of unexpected administrative barriers, only 5 cases were enrolled in a year.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 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 Healthy, 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: stopped early, as of the sponsor's last update on 19 May 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 stopped early (reason given: Beacuse of unexpected administrative barriers, only 5 cases were enrolled in a year.). Results are not available in the source record.
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 19 May 2009.