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Study Summary
No. 2006-0487:.......Head And Neck; Pediatrics......Winston Huh......Pediatrics
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Study Summary Title
Study Summary
Number:		2006-0487
Study Title:Carotid Artery Disease in Long-Term Survivors of Childhood Cancer
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Physician New Patient Referral
Name:Winston HuhPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:PediatricsReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6620
Contact us about clinical trials
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General Information
Disease Group:Head And Neck
Pediatrics		Supported By:N/A
Phase of Study:N/AReturn
Visit:		This is a one time observational study and data will be captured during their
routinely scheduled yearly visit to the Long-Term Follow Up Clinic for the
Division of Pediatrics.
Treatment
Agents:		NoneHome Care:Not applicable
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Not applicable
Description/
Intervention:		The goal of this clinical research study is to find out if long-term survivors
of childhood head or neck cancer, who received radiation therapy as part of the
overall treatment plan, are at increased risk of thickening or blockage of the
carotid arteries (the major blood vessels in the neck).

Researchers also want to find out if other medical conditions, such as high
blood sugar, high blood cholesterol, or history of tobacco use may contribute
to the thickening or blockage of the carotid arteries.
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Study Objectives / Outcomes
    Primary Objective
1.1 To prospectively determine the mean difference of carotid artery intima-media thickening (IMT) between the irradiated and non-irradiated sides of the neck in long-term survivors of pediatric cancers who received unilateral radiation therapy involving the carotid artery as part of their treatment.
    Secondary Objectives
1.2 To prospectively determine the point prevalence of internal carotid artery stenosis (CAS) in long-term survivors of pediatric cancers who received unilateral radiation therapy involving the carotid artery as part of their treatment.

1.3 Compare the clinical characteristics (history of hypertension, dyslipidemia, etc), treatment characteristics (histology, location, chemotherapy and radiation dose) and demographic data of these patients in order to identify risk factors associated with clinically significant carotid artery abnormalities and any identified history of vascular events.

1.4 To determine the point prevalence of CAS and estimate the IMT in long-term survivors of pediatric cancers who received bilateral neck radiation therapy.
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Study Status Information
Study Activation / Registration Date:12/19/2007
IRB Review and Approval Date:04/27/2007
Study Type:Observational
Recruitment Status:Terminated
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Subjects must have been less than 21 years of age at time of initial diagnosis.

2) Patients treated at M.D. Anderson Cancer Center for any malignancy (including primary CNS tumors) that required radiation therapy to the head and neck area and involving the carotid artery as part of the overall treatment plan.

3) Patients must be at least 5 years status post completion of therapy.

4) Must be English speaking, or able to consent through an approved medical language translator.

5) A written informed consent from the patient and/or the patient's legally authorized guardian must be obtained from all patients.
Exclusion Criteria:1) Leukemia patients receiving craniospinal irradiation

2) Non-English speaking subjects for which no appropriate medical translator is available
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Links
Registration Number: NCT00591539
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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