The ONCOCAMP Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Oncology
• Intervention / Treatment: Other: Data collection (retrospective); Other: Data collection (prospective)

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.

• Study Type: Observational
• Enrollment (Estimated): 15000

Contacts and Locations

• Study Contact: Name: Sandro Pignata, M.D.; Phone Number: 08117770755; Email: s.pignata@istitutotumori.na.it

Study Locations

• Italy
  • Avellino, Italy, 83100
    • Recruiting
    • A.O. Moscati
    • Contact: Cesare Gridelli, M.D.
  • Avellino, Italy, 83100
    • Recruiting
    • ASL Avellino
    • Contact: Giuseppe Genua, M.D.
  • Benevento, Italy, 82100
    • Recruiting
    • A.O. Rummo
    • Contact: Antonio Grimaldi, M.D.
  • Benevento, Italy, 82100
    • Recruiting
    • Asl Benevento
    • Contact: Elena Fossi, M.D.
  • Caserta, Italy, 81035
    • Recruiting
    • ASL Caserta
    • Contact: Antonella Guida, M.D.
  • Caserta, Italy, 81100
    • Recruiting
    • A.O. S.Anna S. Sebastiano
    • Contact: Michele Orditura, M.D.
  • Napoli, Italy, 80147
    • Recruiting
    • Ospedale del Mare
    • Contact: Bruno Daniele, M.D.
  • Napoli, Italy, 80131
    • Recruiting
    • A.O. Cardarelli
    • Contact: Ferdinando Riccardi, M.D.
  • Napoli, Italy, 80131
    • Recruiting
    • A.O. Dei Colli
    • Contact: Vincenzo Montesarchio, M.D.
  • Napoli, Italy, 80131
    • Recruiting
    • Federico II
    • Contact: Sabino De Placido, M.D.
  • Napoli, Italy, 80131
    • Recruiting
    • I.N.T. Pascale
    • Contact: Sandro Pignata, M.D.
  • Napoli, Italy, 80138
    • Recruiting
    • A.O.U. Luigi Vanvitelli
    • Contact: Fortunato Ciardiello, M.D.
  • Napoli, Italy, 80145
    • Recruiting
    • Asl Napoli 1 Centro
    • Contact: Tiziana Spinosa, M.D.
  • Salerno, Italy, 84124
    • Recruiting
    • Asl Salerno
    • Contact: Giuseppe Di Lorenzo, M.D.
  • Salerno, Italy, 84126
    • Recruiting
    • A.O.U. Ruggi
    • Contact: Stefano Pepe, M.D.
  • Napoli
    • Casavatore, Napoli, Italy, 80020
      • Recruiting
      • Asl Napoli 2 Nord
      • Contact: Filomena Sibilio, M.D.
    • Ercolano, Napoli, Italy, 80056
      • Recruiting
      • ASL Napoli 3 sud
      • Contact: Mario Fusco, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

Inclusion Criteria:

• signed informed consent
• registration in the ROC platform

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A (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	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
Cohort B (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).	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
Spatial analysis for each patient	Spatial analysis for each patient	Every year up to 5 years
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
Percentage of patient included in clinical trial	Percentage of patient included in clinical trial	Every 2 months up to 5 years
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of pharmacological strategies	Evaluation of pharmacological strategies	Every year up to 5 years
Description of diagnostic activities	Evaluation of diagnostic activities	Every year up to 5 years
Description of surgical strategies	Evaluation of surgical strategies	Every year up to 5 years
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
Description of each surgical approach	Description of each surgical approach	Every year up to 5 years
Description of the different surgical techniques among the centers	Description of the different surgical techniques among the centers	Every year up to 5 years
Patients' quality of life	Patients' quality of life using questionnaires	Every year up to 5 years
Patients' reported outcome	Patients' reported outcome using questionnaires	Every year up to 5 years
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
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
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
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
Survival analysis for each tumor	Survival analysis for each tumor	Every 2 years up to 6 years
Life status assessment for each patient	Life status assessment for each patient	Every year up to 5 years

Collaborators and Investigators

• Sponsor: National Cancer Institute, Naples
• Investigators: Principal Investigator: Sandro Pignata, M.D., IRCCS I.N.T. "G. Pascale"

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Estimated): February 21, 2024

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Oncological Network; Multidisciplinary Oncology Groups
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ONCOCAMP; 6/23 oss (Other Identifier: IRCCS I.N.T. "G. Pascale")

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No