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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00591539 |
Purpose
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 | Intervention |
|---|---|
|
Pediatric Cancers |
Procedure: Carotid Ultrasound |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Carotid Artery Disease in Long-Term Survivors of Childhood Cancer |
| Enrollment: | 3 |
| Study Start Date: | December 2007 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Carotid Ultrasound
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.
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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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Long-term survivors of pediatric cancers who received radiation therapy to the neck as part of their treatment at M.D. Anderson Cancer Center.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Winston Huh, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Winston Huh, MD/Assistant Professor, U.T.M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00591539 History of Changes |
| Other Study ID Numbers: | 2006-0487 |
| Study First Received: | December 28, 2007 |
| Last Updated: | October 11, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Carotid Artery Disease Intima-Media Thickening Carotid Ultrasound Pediatric Cancer Survivors |
Cancer Survivors Head or Neck Cancer Radiation Therapy |
|
Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
