The ONCOCAMP Study

December 16, 2025 updated by: National Cancer Institute, Naples

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence for each tumor of the patients included in the ROC platform
Time Frame: Every year up to 5 years
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 Frame: Every 6 months up to 3 years
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 Frame: Every 6 months up to 3 years
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 Frame: Every 6 months up to 3 years
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 Frame: Every 6 months up to 3 years
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 Frame: Every 6 months up to 3 years
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
Time Frame: Every 2 months up to 5 years
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)
Time Frame: Every 6 months up to 5 years
Descriptive analysis of each subgroup of patients (subdivision by tumor type)
Every 6 months up to 5 years
Spatial analysis for each patient
Time Frame: Every year up to 5 years
Spatial analysis for each patient
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
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
Time Frame: Every 2 months up to 5 years
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
Time Frame: Every 6 months up to 5 years
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
Time Frame: Every year up to 5 years
Prevalence for each tumor of the patients included in the ROC platform
Every year up to 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Description of pharmacological strategies
Time Frame: Every year up to 5 years
Evaluation of pharmacological strategies
Every year up to 5 years
Description of diagnostic activities
Time Frame: Every year up to 5 years
Evaluation of diagnostic activities
Every year up to 5 years
Description of surgical strategies
Time Frame: Every year up to 5 years
Evaluation of surgical strategies
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
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
Time Frame: Every year up to 5 years
Description of each surgical approach
Every year up to 5 years
Description of the different surgical techniques among the centers
Time Frame: Every year up to 5 years
Description of the different surgical techniques among the centers
Every year up to 5 years
Patients' quality of life
Time Frame: Every year up to 5 years
Patients' quality of life using questionnaires
Every year up to 5 years
Patients' reported outcome
Time Frame: Every year up to 5 years
Patients' reported outcome using questionnaires
Every year up to 5 years
Patients' satisfaction and evaluation of the diagnostic / therapeutic path
Time Frame: Every year up to 5 years
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
Time Frame: Every year up to 5 years
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
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
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
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
Time Frame: Every 2 years up to 6 years
Survival analysis for each tumor
Every 2 years up to 6 years
Life status assessment for each patient
Time Frame: Every year up to 5 years
Life status assessment for each patient
Every year up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Institute, Naples

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sandro Pignata, M.D., IRCCS I.N.T. "G. Pascale"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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