NCT00712998

Brief 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).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

May 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
Last Updated

May 19, 2009

Status Verified

March 1, 2008

Enrollment Period

2 months

First QC Date

July 9, 2008

Last Update Submit

May 17, 2009

Conditions

Keywords

radiation injuriesfree radicalsreactive oxygen speciesradiation injury from X-ray computed tomographyfree radical productionblood reactive oxygen species level

Study Arms (3)

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.

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

participants of health check program at our hospital

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NTUH

Taipei, 10016, Taiwan

Location

Biospecimen

Retention: NONE RETAINED

only peripheral blood will be collected for measurement of reactive oxygen species.

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Zei-Shung Huang, MD, PhD

    NTUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 11, 2008

Study Start

May 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

May 19, 2009

Record last verified: 2008-03

Locations