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Carotid Artery Disease in Long-Term Survivors of Childhood Cancer


N/A
N/A
21 Years
Not Enrolling
Both
Pediatric Cancers

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Trial Information

Carotid Artery Disease in Long-Term Survivors of Childhood Cancer


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.


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 unilateral radiation therapy to the head and neck area and
involving the ipsilateral 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

3. Patients who received head/neck radiation involving both carotid arteries will not be
eligible.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Patients with Carotid intima-media thickening (IMT)

Outcome Time Frame:

Carotid ultrasound testing and laboratory examinations performed at time of routinely scheduled yearly appointment.

Safety Issue:

No

Principal Investigator

Winston Huh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0487

NCT ID:

NCT00591539

Start Date:

December 2007

Completion Date:

August 2010

Related Keywords:

  • Pediatric Cancers
  • Carotid Artery Disease
  • Intima-Media Thickening
  • Carotid Ultrasound
  • Pediatric Cancer Survivors
  • Cancer Survivors
  • Head or Neck Cancer
  • Radiation Therapy
  • Carotid Artery Diseases

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030