Carotid Artery Disease in Childhood Cancer Survivors
Carotid Artery Disease in Long-Term Survivors of Childhood Cancer
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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Texas
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Houston, Texas, Spojené státy, 77030
- UT MD Anderson Cancer Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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
|
Bilateral carotid ultrasound measurements: A test that uses sound waves to look at the blood vessels in the neck.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Patients with Carotid intima-media thickening (IMT)
Časové okno: Carotid ultrasound testing and laboratory examinations performed at time of routinely scheduled yearly appointment.
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Carotid ultrasound testing and laboratory examinations performed at time of routinely scheduled yearly appointment.
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Patients with Carotid artery stenosis (CAS)
Časové okno: Carotid ultrasound testing and laboratory examinations performed at time of routinely scheduled yearly appointment.
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Carotid ultrasound testing and laboratory examinations performed at time of routinely scheduled yearly appointment.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Winston Huh, MD, M.D. Anderson Cancer Center
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2006-0487
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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