Carotid Artery Disease in Childhood Cancer Survivors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00591539|
Recruitment Status : Terminated (Slow Accrual.)
First Posted : January 11, 2008
Last Update Posted : July 31, 2012
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.
|Condition or disease||Intervention/treatment|
|Pediatric Cancers||Procedure: Carotid Ultrasound|
Some research shows that survivors of adult head or neck cancer, who received radiation therapy, are at increased risk for thickening or blockage of the carotid arteries, which may increase the risk for other medical conditions, such as stroke. Researchers want to learn about the possible risks of thickening or blockage of the carotid arteries in survivors of childhood head or neck cancer.
If you agree to take part in this study, researchers will see if there are any possible effects (thickening or blockage) of radiation therapy on your carotid arteries. This will be done by examining the test results from routine testing (mentioned below) that is normally done for your standard long-term follow-up care of the disease. These routine tests would be performed even if you were not in this research study.
During your long-term follow-up clinic appointment, you will have a physical exam and an ultrasound test (performed at the Cardiology Clinic) of the carotid arteries. A carotid ultrasound is a test that uses sound waves to look at the blood vessels in the neck. Blood will be drawn (about 2-3 teaspoons) for laboratory tests, including blood sugar level, blood cholesterol level, blood triglyceride level, thyroid hormone level, and blood levels of certain proteins (C-reactive protein and brain natriuretic peptide).
If any of the tests show any thickening or blockage of the carotid arteries or other medical problems, such as high blood sugar, your study doctor will discuss the test results, treatment options, and/or a follow-up plan with you.
This is an investigational study. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
|Study Type :||Observational|
|Actual Enrollment :||3 participants|
|Official Title:||Carotid Artery Disease in Long-Term Survivors of Childhood Cancer|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
Carotid Ultrasound: 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
Procedure: Carotid Ultrasound
Bilateral carotid ultrasound measurements: A test that uses sound waves to look at the blood vessels in the neck.
- Patients with Carotid intima-media thickening (IMT) [ Time Frame: Carotid ultrasound testing and laboratory examinations performed at time of routinely scheduled yearly appointment. ]
- Patients with Carotid artery stenosis (CAS) [ Time Frame: Carotid ultrasound testing and laboratory examinations performed at time of routinely scheduled yearly appointment. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591539
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Winston Huh, MD||M.D. Anderson Cancer Center|