The Ambidirectional Cohort Study of Neurovascular Complications After Radiation Therapy in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Significant intracranial artery stenosis
研究概览
简要总结
Head and neck cancer is a group of cancers develop from the soft tissues, salivary gland, mucosa of the upper respiratory or digestive system covering the oral and nasal cavity. Radiotherapy is usually the standard treatment of Head and neck cancers. In the present study, investigators aim to study the prevalence of cervical-cranial vascular complications during the early stages in these Head and neck cancer patients receiving Radiotherapy. Investigators will also compare the results between Nasopharyngeal cancer and other Head and neck cancerpatients receiving Radiotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Population: Prospective cohort
- •Inclusion Criteria:
- •Age ≥20 years.
- •Head and neck cancer patient .
- •Had ever received radiation therapy (RT) ≦ 72 months before inclusion in the registry.
- •Had ≥ 1 brain images and cervical-cranial vascular studies between the end of RT and d date of enrolment.
排除标准
- •Age <20 years.
- •Patients not willing to sign the informed consent.
- •Population: Retrospective validation cohort
- •Inclusion Criteria:
- •Age ≥20 years.
- •Head and neck cancer patient.
- •Had ever received radiation therapy (RT) > 120 months before the adoption date of IRB at the participant site.
- •Had ≥ 2 brain images and cervical-cranial vascular studies between the end of RT and 6~10 years after RT, one within 5 years after RT, the other after 5 years after RT.
- •Exclusion Criteria:
- •1.Age <20 years.
结局指标
主要结局
Significant intracranial artery stenosis
时间窗: 1 year
Presence of \> 50% stenosis at intracranial ICA/VA, basilar artery, middle cerebral artery, anterior cerebral artery, or anterior cerebral artery.
Presence of carotid blow-out syndrome
时间窗: 1 year
Carotid blow out syndrome was categorized as type 1 (threaten type), type 2 (impending blowouts), and type 3 (acute CBS hemorrhage).
Presence of hypothyroidism
时间窗: 1 year
Clinical hypothyroidism was diagnosed when a patient had free T4 ≤ 0.80 ng/dL with elevated TSH (\>5.0 mU/L).
Significant CAS at internal carotid artery or common carotid artery
时间窗: 1 year
We define significant CAS as (a) \>50% stenosis on the B-mode with peak systolic velocities ≥120 cm/s based on the hemodynamic criteria at any internal carotid artery or common carotid artery in the CDU study according to the standard ultrasound criteria35; or (b) \> 50% diameter stenosis on the follow up CT or MR images.
Cerebral infarctions (CI)
时间窗: 1 year
The CI is defined whenever there were symptomatic IS occurrence of presence of asymptomatic IS on the reviewed brain MRIs.
Significant extracranial vertebral artery stenosis (VAS)
时间窗: 1 year
\> 50% diameter stenosis on the follow up CT or MR images.
Presence of TLN
时间窗: 1 year
We will identify white matter lesions, contrast-enhanced lesions, Cysts, and local mass effect. The white matter lesions in the temporal lobe will be divided into three groups: mild (small focal areas), moderate (larger confluent areas) and severe (large confluent areas extending outside the radiation field with or without local mass effect). The cysts will be evaluated for size and number. The local mass effect will be classified as mild (affecting only the temporal lobe sulci), moderate (affecting the sulci and ventricles) and severe (affecting the midline of the brain).
Tumor recurrence
时间窗: 1 year
Relapse
Mortality
时间窗: 1 year
Death
次要结局
未报告次要终点