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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00712998
Other study ID # 200803085R
Secondary ID
Status Terminated
Phase N/A
First received July 9, 2008
Last updated May 17, 2009
Start date May 2008
Est. completion date July 2008

Study information

Verified date March 2008
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical 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]. 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).


Recruitment information / eligibility

Status Terminated
Enrollment 60
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

- Those whose age are under 50 or above 70 year-olds will be excluded.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan NTUH Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

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