A Retrospective-prospective, Observational, Multicentric Study to Record Data From the ROC Platform and Monitor the ROC Performance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15,000
- 试验地点
- 17
- 主要终点
- Incidence for each tumor of the patients included in the ROC platform
研究概览
简要总结
The present study is a retrospective-prospective observational and multicentric study aiming to collect data relating to all patients included in the ROC platform. All ROC centers will be involved in the present study.
详细描述
The ROC platform therefore represents a multicenter database and a growing source of data and information regarding cancer patients in the Campania region. The need for multicenter databases is supported by the results obtained with both retrospective and prospective studies. Many retrospective studies have led to changes in some of the available guidelines. Important advantages of this study include representativeness of the analyzed cohort to all patients with a specific cancer and a large sample size that provides sufficient statistical power to detect differences across different patient groups. The data extracted from the ROC have the potential to produce knowledge, to guide decision-making, and to manage more effectively the challenges of fighting cancer in our region. The Campania region counts more than 6 million people, and it is characterized by a worst oncological outcome compared to the average data of other Italian region: the ROC platform has the potential to analyze the effect of a public intervention in the field of oncology care. Therefore, the primary aim of this study is to create a retrospective-prospective registry of all cancer patients entering the ROC platform and in a GOM path describing the primary and secondary endpoints.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •signed informed consent
- •registration in the ROC platform
排除标准
- 未提供
结局指标
主要结局
Incidence for each tumor of the patients included in the ROC platform
时间窗: Every year up to 5 years
Incidence for each tumor of the patients included in the ROC platform
Evaluation of the time interval between GOM activities
时间窗: Every 6 months up to 3 years
Time interval betweenthe date diagnosis and the GOM meeting date
Frequency of use of the services of the ROC platform
时间窗: Every 2 months up to 5 years
Frequency of use of the services of the ROC platform
Prevalence for each tumor of the patients included in the ROC platform
时间窗: Every year up to 5 years
Prevalence for each tumor of the patients included in the ROC platform
Spatial analysis for each patient
时间窗: Every year up to 5 years
Spatial analysis for each patient
Percentage of patient included in clinical trial
时间窗: Every 2 months up to 5 years
Percentage of patient included in clinical trial
Descriptive analysis of each subgroup of patients (subdivision by tumor type)
时间窗: Every 6 months up to 5 years
Descriptive analysis of each subgroup of patients (subdivision by tumor type)
Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA)
时间窗: Every 6 months up to 5 years
Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA)
Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate
时间窗: Every 6 months up to 5 years
Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate
次要结局
- Description of surgical strategies(Every year up to 5 years)
- Description of each surgical approach(Every year up to 5 years)
- Description of the different surgical techniques among the centers(Every year up to 5 years)
- Dependence analysis between the conditions of social deprivation of ROC patients and the time to the first GOM visit(Every year up to 5 years)
- Survival analysis for each tumor(Every 2 years up to 6 years)
- Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis(Every year up to 5 years)
- Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path(Every year up to 5 years)
- Life status assessment for each patient(Every year up to 5 years)
- Description of pharmacological strategies(Every year up to 5 years)
- Description of diagnostic activities(Every year up to 5 years)
- Patients' satisfaction and evaluation of the diagnostic / therapeutic path(Every year up to 5 years)
- Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA)(Every 6 months up to 5 years)
- Patients' quality of life(Every year up to 5 years)
- Patients' reported outcome(Every year up to 5 years)