Carotid Artery Disease in Childhood Cancer Survivors

This study has been terminated.
(Slow Accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00591539
First received: December 28, 2007
Last updated: July 27, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patients with Carotid intima-media thickening (IMT) [ Time Frame: Carotid ultrasound testing and laboratory examinations performed at time of routinely scheduled yearly appointment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients with Carotid artery stenosis (CAS) [ Time Frame: Carotid ultrasound testing and laboratory examinations performed at time of routinely scheduled yearly appointment. ] [ Designated as safety issue: No ]

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.

Detailed Description:

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
Study Population

Long-term survivors of pediatric cancers who received radiation therapy to the neck as part of their treatment at M.D. Anderson Cancer Center.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591539

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Winston Huh, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: 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: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Carotid Artery Disease
Intima-Media Thickening
Carotid Ultrasound
Pediatric Cancer Survivors
Cancer Survivors
Head or Neck Cancer
Radiation Therapy

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014