AtherosclerosisNCT00590421
Carotid Atherosclerotic Disease Following Childhood Scalp Irradiation
An observational study of Atherosclerosis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Background: During the first half of the 20th century, scalp irradiation was a standard treatment for induction of epilation in children suffering from Tinea Capitis. These children are now more than 50 years old and the aim was to investigate the possible association between their childhood low dose irradiation… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- How many people
- 295 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2004to Nov 2007
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study was designed to include 150 persons who were treated as children for Tinea Capitis by scalp irradiation in the 1950's and 150 subjects who were not exposed to radiation. This sample size was determined under the following assumption: power of ≥95%, alpha error level of 5%, 10% prevalence of carotid stenosis in the non exposed group and minimal OR of 2.5.
Who may be able to join
- age 18 or older
- childhood scalp irradiation or mach controls
- writen informed consent
Who cannot join
- inability to give written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Background: During the first half of the 20th century, scalp irradiation was a standard treatment for induction of epilation in children suffering from Tinea Capitis. These children are now more than 50 years old and the aim was to investigate the possible association between their childhood low dose irradiation exposure and development of carotid atherosclerotic disease in adulthood.
Methods: The study included 145 individuals treated by irradiation in their childhood, and 150 matched control subjects with no history of irradiation. B-mode ultrasound imaging and US Doppler were used to measure carotid and femoral stenosis and Intima-Media Thickness (IMT). Blood samples were taken for lipid profile and homocysteine evaluation.
- Conditions
- Atherosclerosis
- Medical subject headings
- Atherosclerosis
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 | 145 individuals treated by irradiation in their childhood | |
| 2 | 150 matched control subjects with no history of irradiation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startJul 2004
- Primary completionJan 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Shai Efrati, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590421
- Sponsor's protocol ID
- Car&RAD05
- Other IDs
- 57/04
- Status last verified
- Dec 2007
- First submitted
- 31 Dec 2007
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Atherosclerotic Disease Following Childhood Scalp Irradiation
- ClinicalTrials.gov ID
- NCT00590421
- Acronym / sponsor ID
- Car&RAD05
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jul 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 10 Jan 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.
Background: During the first half of the 20th century, scalp irradiation was a standard treatment for induction of epilation in children suffering from Tinea Capitis. These children are now more than 50 years old and the aim was to investigate the possible association between their childhood low dose irradiation exposure and development of carotid atherosclerotic disease in adulthood.
Methods: The study included 145 individuals treated by irradiation in their childhood, and 150 matched control subjects with no history of irradiation. B-mode ultrasound imaging and US Doppler were used to measure carotid and femoral stenosis and Intima-Media Thickness (IMT). Blood samples were taken for lipid profile and homocysteine evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –145 individuals treated by irradiation in their childhood |
| 2 | – | –150 matched control subjects with no history of irradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study was designed to include 150 persons who were treated as children for Tinea Capitis by scalp irradiation in the 1950's and 150 subjects who were not exposed to radiation. This sample size was determined under the following assumption: power of ≥95%, alpha error level of 5%, 10% prevalence of carotid stenosis in the non exposed group and minimal OR of 2.5.
Key inclusion criteria (3 listed)
- age 18 or older
- childhood scalp irradiation or mach controls
- writen informed consent
Key exclusion criteria (1 listed)
- inability to give written informed consent
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
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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.
Shai Efrati, MD principal investigator
Assaf-Harofeh Medical Center
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 Atherosclerosis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 3 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: finished, as of the sponsor's last update on 17 Oct 2008. 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 Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 17 Oct 2008.