Clinical trial NCT06270602: The ONCOCAMP Study
Official title: A Retrospective-prospective, Observational, Multicentric Study to Record Data From the ROC Platform and Monitor the ROC Performance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oncology
Keywords: Oncological Network
Multidisciplinary Oncology Groups
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. 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 (The retrospective cohort will be made by more than 40000 patients already included in the platform and entered a GOM path.
2. 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).

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.

Eligibility criteria: Inclusion Criteria:

* signed informed consent
* registration in the ROC platform

Primary outcomes:
measure: Incidence for each tumor of the patients included in the ROC platform
timeFrame: Every year up to 5 years
measure: Evaluation of the time interval between GOM activities
timeFrame: Every 6 months up to 3 years
measure: Evaluation of the time interval between GOM activities
timeFrame: Every 6 months up to 3 years
measure: Evaluation of the time interval between GOM activities
timeFrame: Every 6 months up to 3 years
measure: Evaluation of the time interval between GOM activities
timeFrame: Every 6 months up to 3 years
measure: Evaluation of the time interval between GOM activities
timeFrame: Every 6 months up to 3 years
measure: Frequency of use of the services of the ROC platform
timeFrame: Every 2 months up to 5 years
measure: Descriptive analysis of each subgroup of patients (subdivision by tumor type)
timeFrame: Every 6 months up to 5 years
measure: Spatial analysis for each patient
timeFrame: Every year up to 5 years
measure: Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA)
timeFrame: Every 6 months up to 5 years
measure: Percentage of patient included in clinical trial
timeFrame: Every 2 months up to 5 years
measure: Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate
timeFrame: Every 6 months up to 5 years
measure: Prevalence for each tumor of the patients included in the ROC platform
timeFrame: Every year up to 5 years
Secondary outcomes:
measure: Description of pharmacological strategies
timeFrame: Every year up to 5 years
measure: Description of diagnostic activities
timeFrame: Every year up to 5 years
measure: Description of surgical strategies
timeFrame: Every year up to 5 years
measure: Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA)
timeFrame: Every 6 months up to 5 years
measure: Description of each surgical approach
timeFrame: Every year up to 5 years
measure: Description of the different surgical techniques among the centers
timeFrame: Every year up to 5 years
measure: Patients' quality of life
timeFrame: Every year up to 5 years
measure: Patients' reported outcome
timeFrame: Every year up to 5 years
measure: Patients' satisfaction and evaluation of the diagnostic / therapeutic path
timeFrame: Every year up to 5 years
measure: Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis
timeFrame: Every year up to 5 years
measure: Dependence analysis between the conditions of social deprivation of ROC patients and the time to the first GOM visit
timeFrame: Every year up to 5 years
measure: Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path
timeFrame: Every year up to 5 years
measure: Survival analysis for each tumor
timeFrame: Every 2 years up to 6 years
measure: Life status assessment for each patient
timeFrame: Every year up to 5 years
Other outcomes:
Locations:
city: Casavatore
country: Italy
facility: Asl Napoli 2 Nord
state: Napoli
city: Ercolano
country: Italy
facility: Asl Napoli 3 Sud
state: Napoli
city: Avellino
country: Italy
facility: A.O. Moscati
city: Avellino
country: Italy
facility: Asl Avellino
city: Benevento
country: Italy
facility: A.O. Rummo
city: Benevento
country: Italy
facility: Asl Benevento
city: Caserta
country: Italy
facility: Asl Caserta
city: Caserta
country: Italy
facility: A.O. S.Anna S. Sebastiano
city: Napoli
country: Italy
facility: A.O. Cardarelli
city: Napoli
country: Italy
facility: A.O. Dei Colli
city: Napoli
country: Italy
facility: Federico II
city: Napoli
country: Italy
facility: I.N.T. Pascale
city: Napoli
country: Italy
facility: A.O.U. Luigi Vanvitelli
city: Napoli
country: Italy
facility: Asl Napoli 1 Centro
city: Napoli
country: Italy
facility: Ospedale del Mare
city: Salerno
country: Italy
facility: Asl Salerno
city: Salerno
country: Italy
facility: A.O.U. Ruggi
Study officials:
affiliation: IRCCS I.N.T. "G. Pascale"
name: Sandro Pignata, M.D.
role: PRINCIPAL_INVESTIGATOR
References: