A Retrospective-prospective, Observational, Multicentric Study to Record Data From the ROC Platform and Monitor the ROC Performance
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oncology
- Sponsor
- National Cancer Institute, Naples
- Enrollment
- 15000
- Locations
- 17
- Primary Endpoint
- Incidence for each tumor of the patients included in the ROC platform
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •signed informed consent
- •registration in the ROC platform
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence for each tumor of the patients included in the ROC platform
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Every year up to 5 years
Prevalence for each tumor of the patients included in the ROC platform
Spatial analysis for each patient
Time Frame: Every year up to 5 years
Spatial analysis for each patient
Percentage of patient included in clinical trial
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: Every 6 months up to 5 years
Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate
Secondary Outcomes
- 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)