The ONCOCAMP Study

Official title

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

Overview

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.

Interventions

• 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
• Other 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

Primary outcome measures

• Incidence for each tumor of the patients included in the ROC platform [Time frame: Every year up to 5 years]
• Evaluation of the time interval between GOM activities [Time frame: Every 6 months up to 3 years]
• Evaluation of the time interval between GOM activities [Time frame: Every 6 months up to 3 years]
• Evaluation of the time interval between GOM activities [Time frame: Every 6 months up to 3 years]
• Evaluation of the time interval between GOM activities [Time frame: Every 6 months up to 3 years]
• Evaluation of the time interval between GOM activities [Time frame: Every 6 months up to 3 years]
• Frequency of use of the services of the ROC platform [Time frame: Every 2 months up to 5 years]
• Descriptive analysis of each subgroup of patients (subdivision by tumor type) [Time frame: Every 6 months up to 5 years]
• Spatial analysis for each patient [Time frame: Every year up to 5 years]
• Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA) [Time frame: Every 6 months up to 5 years]

Secondary outcome measures (12)

• Description of pharmacological strategies [Time frame: Every year up to 5 years]
• Description of diagnostic activities [Time frame: Every year up to 5 years]
• Description of surgical strategies [Time frame: Every year up to 5 years]
• Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA) [Time frame: Every 6 months up to 5 years]
• Description of each surgical approach [Time frame: Every year up to 5 years]
• Description of the different surgical techniques among the centers [Time frame: Every year up to 5 years]
• Patients' quality of life [Time frame: Every year up to 5 years]
• Patients' reported outcome [Time frame: Every year up to 5 years]
• Patients' satisfaction and evaluation of the diagnostic / therapeutic path [Time frame: Every year up to 5 years]
• Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis [Time frame: 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 [Time frame: Every year up to 5 years]
• Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path [Time frame: Every year up to 5 years]

Eligibility criteria

Inclusion criteria

• signed informed consent
• registration in the ROC platform

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 17 centers

• A.O. Moscati — Avellino
• Asl Avellino — Avellino
• A.O. Rummo — Benevento
• Asl Benevento — Benevento
• Asl Caserta — Caserta
• A.O. S.Anna S. Sebastiano — Caserta
• Asl Napoli 2 Nord — Casavatore
• Asl Napoli 3 Sud — Ercolano
• … and 9 more centers

Publications

• Porciello G, Crispo A, Di Carlo FPM, Rocco P, Luongo A, Russo N, Palumbo E, Vitale S, Coluccia S, Prete M, Di Lauro T, Abbadessa L, Di Martino A, Mozzillo AL, Racca E, Piccirillo A, Di Giacomo V, D'Amico M, Fontana M, Augustin LSA, D'Errico D, Coppola E, Stallone T, Maiolino P, Parascandolo I, Turra V, Pignata S; NUTRISCREEN Collaborative Research Group. Physical Activity, Nutritional Status, and PMID 41830013
• Porciello G, Di Lauro T, Luongo A, Coluccia S, Prete M, Abbadessa L, Coppola E, Di Martino A, Mozzillo AL, Racca E, Piccirillo A, Di Giacomo V, Fontana M, D'Amico M, Palumbo E, Vitale S, D'Errico D, Turra V, Parascandolo I, Stallone T, Augustin LSA, Crispo A, Celentano E, Pignata S. Optimizing Nutritional Care with Machine Learning: Identifying Sarcopenia Risk Through Body Composition Parameters i PMID 40284239

Identifiers

NCT: NCT06270602 · ONCOCAMP · 6/23 oss

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗