Carotid Artery Disease in Childhood Cancer Survivors

NCT00591539 | Terminated

• 1 other identifier: 2006-0487
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Cancers

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Patients with Carotid intima-media thickening (IMT)

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

Secondary Outcomes (1)

• Patients with Carotid artery stenosis (CAS)

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

Study Arms (1)

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

Interventions

Carotid Ultrasound PROCEDURE

Bilateral carotid ultrasound measurements: A test that uses sound waves to look at the blood vessels in the neck.

Carotid Ultrasound

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Subjects must have been less than 21 years of age at time of initial diagnosis.
• 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.
• Patients must be at least 5 years status post completion of therapy.
• Must be English speaking, or able to consent through an approved medical language translator.
• A written informed consent from the patient and/or the patient's legally authorized guardian must be obtained from all patients.

You may not qualify if:

• Leukemia patients receiving craniospinal irradiation
• Non-English speaking subjects for which no appropriate medical translator is available
• Patients who received head/neck radiation involving both carotid arteries will not be eligible.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Carotid Artery Diseases; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms

Study Officials

• Winston Huh, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 11, 2008
• Study Start: December 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

US (1)