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Carotid Atherosclerotic Disease Following Childhood Scalp Irradiation

NCT ID: NCT00590421

Last Updated: 2008-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

295 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

145 individuals treated by irradiation in their childhood

No interventions assigned to this group

2

150 matched control subjects with no history of irradiation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age 18 or older
* childhood scalp irradiation or mach controls
* writen informed consent

Exclusion Criteria

* inability to give written informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Assaf-Harofeh Medical Center

Principal Investigators

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Shai Efrati, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh Medical Center

Locations

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Assaf Harofeh Medical Center

Ẕerifin, , Israel

Site Status

Countries

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Israel

Other Identifiers

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57/04

Identifier Type: -

Identifier Source: secondary_id

Car&RAD05

Identifier Type: -

Identifier Source: org_study_id