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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Texas
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Houston, Texas, Stati Uniti, 77030
- UT MD Anderson Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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
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Bilateral carotid ultrasound measurements: A test that uses sound waves to look at the blood vessels in the neck.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Patients with Carotid intima-media thickening (IMT)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Patients with Carotid artery stenosis (CAS)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Winston Huh, MD, M.D. Anderson Cancer Center
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2006-0487
Informazioni su farmaci e dispositivi, documenti di studio
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prodotto fabbricato ed esportato dagli Stati Uniti
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