The ONCOCAMP Study

Oncology Clinical Trial

Official title:

A Retrospective-prospective, Observational, Multicentric Study to Record Data From the ROC Platform and Monitor the ROC Performance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06270602
• Other study ID #: ONCOCAMP
• Secondary ID: 6/23 oss
• Status: Recruiting
• Start date: July 14, 2023
• Est. completion date: July 2026

Study information

• Verified date: January 2024
• Source: National Cancer Institute, Naples
• Contact: Sandro Pignata, M.D.
• Phone: 08117770755
• Email: s.pignata[@]istitutotumori.na.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: July 2026
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• signed informed consent

• registration in the ROC platform

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Intervention

Other:
• Data collection (retrospective)
Collection of patient data entered in the ROC platform from the beginning activation of the platform (November 2018) until the date on which the study is approved by the local ethics committee
• Data collection (prospective)
Collection of patient data entered in the ROC platform from the date in which the study is approved by the local ethical committee

Locations

Country	Name	City	State
Italy	A.O. Moscati	Avellino
Italy	Asl Avellino	Avellino
Italy	A.O. Rummo	Benevento
Italy	Asl Benevento	Benevento
Italy	Asl Napoli 2 Nord	Casavatore	Napoli
Italy	A.O. S.Anna S. Sebastiano	Caserta
Italy	Asl Caserta	Caserta
Italy	Asl Napoli 3 Sud	Ercolano	Napoli
Italy	A.O. Cardarelli	Napoli
Italy	A.O. Dei Colli	Napoli
Italy	A.O.U. Luigi Vanvitelli	Napoli
Italy	Asl Napoli 1 Centro	Napoli
Italy	Federico II	Napoli
Italy	I.N.T. Pascale	Napoli
Italy	Ospedale del Mare	Napoli
Italy	A.O.U. Ruggi	Salerno
Italy	Asl Salerno	Salerno

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence for each tumor of the patients included in the ROC platform	Incidence for each tumor of the patients included in the ROC platform	Every year up to 5 years
Primary	Evaluation of the time interval between GOM activities	Time interval between reporting and taking charge by the GOM, the date diagnosis and the GOM meeting date, the first GOM meeting and the final therapeutic decision, the therapy decision and the therapeutic act, and the request for home assistance and the actual taking in charge by the ASL	Every 6 months up to 3 years
Primary	Evaluation of the time interval between GOM activities	Time interval between the request for home assistance and the actual taking in charge by the ASL	Every 6 months up to 3 years
Primary	Evaluation of the time interval between GOM activities	Time interval between the therapy decision and the therapeutic act	Every 6 months up to 3 years
Primary	Evaluation of the time interval between GOM activities	Time interval between the first GOM meeting and the final therapeutic decision	Every 6 months up to 3 years
Primary	Evaluation of the time interval between GOM activities	Time interval betweenthe date diagnosis and the GOM meeting date	Every 6 months up to 3 years
Primary	Frequency of use of the services of the ROC platform	Frequency of use of the services of the ROC platform	Every 2 months up to 5 years
Primary	Descriptive analysis of each subgroup of patients (subdivision by tumor type)	Descriptive analysis of each subgroup of patients (subdivision by tumor type)	Every 6 months up to 5 years
Primary	Spatial analysis for each patient	Spatial analysis for each patient	Every year up to 5 years
Primary	Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA)	Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA)	Every 6 months up to 5 years
Primary	Percentage of patient included in clinical trial	Percentage of patient included in clinical trial	Every 2 months up to 5 years
Primary	Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate	Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate	Every 6 months up to 5 years
Primary	Prevalence for each tumor of the patients included in the ROC platform	Prevalence for each tumor of the patients included in the ROC platform	Every year up to 5 years
Secondary	Description of pharmacological strategies	Evaluation of pharmacological strategies	Every year up to 5 years
Secondary	Description of diagnostic activities	Evaluation of diagnostic activities	Every year up to 5 years
Secondary	Description of surgical strategies	Evaluation of surgical strategies	Every year up to 5 years
Secondary	Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA)	Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA)	Every 6 months up to 5 years
Secondary	Description of each surgical approach	Description of each surgical approach	Every year up to 5 years
Secondary	Description of the different surgical techniques among the centers	Description of the different surgical techniques among the centers	Every year up to 5 years
Secondary	Patients' quality of life	Patients' quality of life using questionnaires	Every year up to 5 years
Secondary	Patients' reported outcome	Patients' reported outcome using questionnaires	Every year up to 5 years
Secondary	Patients' satisfaction and evaluation of the diagnostic / therapeutic path	Patients' satisfaction and evaluation of the diagnostic / therapeutic path using questionnaires	Every year up to 5 years
Secondary	Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis	Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis	Every year up to 5 years
Secondary	Dependence analysis between the conditions of social deprivation of ROC patients and the time to the first GOM visit	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
Secondary	Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path	Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path	Every year up to 5 years
Secondary	Survival analysis for each tumor	Survival analysis for each tumor	Every 2 years up to 6 years
Secondary	Life status assessment for each patient	Life status assessment for each patient	Every year up to 5 years