AIOCC Italian Registry on Head and Neck Carcinomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 7,000
- 试验地点
- 7
- 主要终点
- types of diagnostic and treatment patterns
研究概览
简要总结
Multicentre, retrospective and prospective observational study aimed to set-up a clinical Italian registry in order to collect information on carcinoma of the Head and Neck.
详细描述
The registry plans to collect data on all patients treated or followed for Head and Neck cancer by the HCP of selected investigational sites in Italy.
Data will be entered manually by HCP staff of each investigational site in the study e-CRF in order to populate the AIR study database. Authorized HCPs will be provided with personal UserID and Password for the access to study eCRF.
For Data analysis an open-source system called Vantage6 will be used. It is a privacy preserving federated learning infrastructure for the secure exchange and analysis of incorporating data located at different sources. Queries will be issued to interrogate the database in order to have descriptive statistics and relevant information to plan the statistical analyses envisioned by the study protocol.
The registry data will support observational studies based on the second hand use of available data. Data collected for the AIR Study could be used also for global collaborative studies performed in Europe and outside the Europe.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Adult patients (age ≥ 18 years old) diagnosed with carcinoma of the Head and Neck. The diagnosis should be done or verified by the expert site entering the information about the patient in the registry. Patients diagnosed with sarcomas and lymphomas are excluded.
- •Patients entering the HCP at any clinical phase of the disease (diagnosis, treatment of primary cancer, treatment of recurrence, treatment of M+ etc.). The HCP will collect information on the entire disease regardless of when it started to manage the patient. The HCP can choose, based on its resources, for how many patients will be able to collect the data.
- •New patients managed by the HCP from 2021 onwards + patients managed by the HCP, in active follow-up at the hospital
排除标准
- •Patients whose medical records are unavailable for review
结局指标
主要结局
types of diagnostic and treatment patterns
时间窗: From the enrollment to the end of the study (5 years)
To document types of diagnostic and treatment patterns by all stages of disease and frequency, and proportion with which they are used in the different stages of Head and Neck cancer.
次要结局
- patients and disease characteristics(From the enrollment to the end of the study (5 years))
- healthcare resource(From the enrollment to the end of the study (5 years))
- treatment outcomes(From the enrollment to the end of the study (5 years))
- benchmark values(From the enrollment to the end of the study (5 years))
- potential benefit(From the enrollment to the end of the study (5 years))
- between differences in mortality and differences in medical practice(From the enrollment to the end of the study (5 years))
- immunization(From the enrollment to the end of the study (5 years))
- econometric approach(From the enrollment to the end of the study (5 years))
- proportion of patients in the different stage of disease(From the enrollment to the end of the study (5 years))
- prognostic factors(From the enrollment to the end of the study (5 years))