NCT00745641

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 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).

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

August 7, 2009

Status Verified

March 1, 2009

Enrollment Period

3 months

First QC Date

September 1, 2008

Last Update Submit

August 5, 2009

Conditions

Keywords

radiation injurycomputed tomographyreactive oxygen speciesfree radicals

Study Arms (1)

1

Sixty patients with abdominal illness and scheduled abdominal X-ray computed tomography examination will be included.

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with abdominal illness that needs a computed tomography examination

You may qualify if:

  • patients with abdominal illness that needs a computed tomography examination

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NTUH

Taipei, 10002, 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

September 1, 2008

First Posted

September 3, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 7, 2009

Record last verified: 2009-03

Locations