A Prospective, Observational, Real-world Study Based on the Register System of Oral and Maxillofacial Malignant Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30,000
- 试验地点
- 7
- 主要终点
- disease-specific survival
研究概览
简要总结
The aim of the study is to construct a register system of oral and maxillofacial malignant tumors based on a prospective, observational, real-world study in north Chinese population.
详细描述
A register system of oral and maxillofacial malignant tumors based on a prospective, observational, real-world study in Chinese population was absent.
The aim of the study is to construct a register system of oral and maxillofacial malignant tumors based on a prospective, observational, real-world study in Chinese population. The variables in the study include social informatics, etiology, and psychological and quality of life, coexistence disease, baseline clinicopathological data, postoperative complications, and long-term follow-up results.
By released annual analysis report, the epidemiological features and prognostic factors of oral and maxillofacial malignant tumors in north Chinese population can be identified.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histological diagnosis of oral and maxillofacial malignant tumors
- •no previous treatment
- •a primary tumor without distant metastasis evidence
- •sites: lip, tongue, buccal mucosa, upper and lower gingiva, floor of the mouth, hard palate, oropharynx, salivary gland, upper and lower jaw, and maxillary sinus
排除标准
- •patients decline to participate the study
- •refusal or inability to receive definitive treatment for the disease
- •recurrent tumors
结局指标
主要结局
disease-specific survival
时间窗: 5 years
Disease-specific survival was calculated as the time from the first operation to the time of death or last follow-up; patients who died from causes other than oral and maxillofacial cancer were defined as survivors at the time of death.
次要结局
- tumor recurrence(5 years)
- postoperative complications(10 days; 42 days; 90 days)
- neck recurrence(5 years)
- multiple primary carcinomas(5 years)
- postoperative change from Baseline in anxiety and depression (Hospital Anxiety and Depression Scale, and Distress Thermometer)(1-5 years)
- preoperative comorbidity(1-5 years)
- Radiotherapy relative complications(10 years)
- postoperative change from Baseline in quality of life score (UW-QOL questionnaire)(1-5 years)
- delay time of cancer diagnosis(0-2 years)
- The correlation among cancer family history, carcinogenesis and prognosis(10 years)
- distant metastasis(5 years)