The ONCOCAMP Study
- Conditions
- Oncology
- Interventions
- Other: Data collection (prospective)Other: Data collection (retrospective)
- Registration Number
- NCT06270602
- Lead Sponsor
- National Cancer Institute, Naples
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15000
- signed informed consent
- registration in the ROC platform
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort B (Prospective): Data collection (prospective) All consecutive patients who enter in the ROC platform as for clinical practice from the date in which the study is approved by the local ethical committee (Investigator is allowed to enroll patients). Cohort A (Retrospective): Data collection (retrospective) All consecutive patients entered in the ROC platform from the start of platform activation (November 2018) until the date in which the study is approved by the local ethical committee (Investigator is allowed to enroll patients) will be enrolled. The retrospective cohort will be made by more than 40000 patients already included in the platform and entered a GOM path
- Primary Outcome Measures
Name Time Method Incidence for each tumor of the patients included in the ROC platform 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 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 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 Every year up to 5 years Prevalence for each tumor of the patients included in the ROC platform
Spatial analysis for each patient Every year up to 5 years Spatial analysis for each patient
Percentage of patient included in clinical trial 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) 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) 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 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 Outcome Measures
Name Time Method Description of surgical strategies Every year up to 5 years Evaluation of surgical strategies
Description of each surgical approach Every year up to 5 years Description of each surgical approach
Description of the different surgical techniques among the centers Every year up to 5 years Description of the different surgical techniques among the centers
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 Dependence analysis between the conditions of social deprivation of ROC patients and the time to the first GOM visit
Survival analysis for each tumor Every 2 years up to 6 years Survival analysis for each tumor
Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis Every year up to 5 years Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis
Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path Every year up to 5 years Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path
Life status assessment for each patient Every year up to 5 years Life status assessment for each patient
Description of pharmacological strategies Every year up to 5 years Evaluation of pharmacological strategies
Description of diagnostic activities Every year up to 5 years Evaluation of diagnostic activities
Patients' satisfaction and evaluation of the diagnostic / therapeutic path Every year up to 5 years Patients' satisfaction and evaluation of the diagnostic / therapeutic path using questionnaires
Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA) Every 6 months up to 5 years Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA)
Patients' quality of life Every year up to 5 years Patients' quality of life using questionnaires
Patients' reported outcome Every year up to 5 years Patients' reported outcome using questionnaires
Trial Locations
- Locations (17)
A.O. S.Anna S. Sebastiano
🇮🇹Caserta, Italy
A.O. Moscati
🇮🇹Avellino, Italy
A.O. Rummo
🇮🇹Benevento, Italy
A.O. Dei Colli
🇮🇹Napoli, Italy
Federico II
🇮🇹Napoli, Italy
I.N.T. Pascale
🇮🇹Napoli, Italy
A.O.U. Luigi Vanvitelli
🇮🇹Napoli, Italy
A.O.U. Ruggi
🇮🇹Salerno, Italy
Asl Napoli 1 Centro
🇮🇹Napoli, Italy
Ospedale del Mare
🇮🇹Napoli, Italy
Asl Salerno
🇮🇹Salerno, Italy
Asl Napoli 2 Nord
🇮🇹Casavatore, Napoli, Italy
Asl Avellino
🇮🇹Avellino, Italy
Asl Napoli 3 Sud
🇮🇹Ercolano, Napoli, Italy
Asl Benevento
🇮🇹Benevento, Italy
Asl Caserta
🇮🇹Caserta, Italy
A.O. Cardarelli
🇮🇹Napoli, Italy