The Clinical Study of Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma Treated by IMRT
试验速览
- 阶段
- 不适用
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- intima media thickness of carotid artery
研究概览
简要总结
Radiation-associated carotid vasculopathy is a common late sequelae in patients with head and neck cancer, which correlates with the incidence of stroke. Currently, little is known about the incidence of radiation-associated carotid vasculopahty in the context of intensity-modulated radiation therapy (IMRT).
The aim of this study is to determine whether IMRT will increase the incidence of carotid vasculopathy in patients with nasopharyngeal carcinoma (NPC).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed inform consent
- •age more than 18 years old
- •pathologic diagnosed, non-metastatic NPC
- •either untreated or treated by definitive IMRT 3 years ago
- •did not receive radiation to the head and neck region prior to the diagnosis of NPC
- •if the patient received definitive IMRT 3 years ago because of NPC, he or she did not receive a second course of radiation due to local relapse
- •no prior surgery of head and neck
排除标准
- •prior history of cardiovascular disease before the diagnosis of NPC
- •prior radiation to head and neck before the diagnosis of NPC
- •prior surgery of head and neck
- •pregnant or lactating women
结局指标
主要结局
intima media thickness of carotid artery
时间窗: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
the intima media thickness of common carotid artery, internal carotid artery of the left or right side
次要结局
- total number of Montreal Cognitive Score (range: 0-30)(This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.)
- the number of carotid plaques(This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.)
- the incidence of carotid stenosis(This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.)
研究者
Xiayun He, MD
Principal Investigator, Clinical Professor
Fudan University