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NCT Number: NCT06270602

The ONCOCAMP Study

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.

Recruiting

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Key information

Conditions

Oncology Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A.O. Moscati, Avellino, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • signed informed consent
  • registration in the ROC platform

Treatment and study plan

Data collection (retrospective)

Other

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)

Other

Collection of patient data entered in the ROC platform from the date in which the study is approved by the local ethical committee

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)

  9. Spatial analysis for each patient

    Time frame: Every year up to 5 years

    Spatial analysis for each patient

  10. 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)

  11. Percentage of patient included in clinical trial

    Time frame: Every 2 months up to 5 years

    Percentage of patient included in clinical trial

  12. 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

  13. 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

Secondary outcomes

  1. Description of pharmacological strategies

    Time frame: Every year up to 5 years

    Evaluation of pharmacological strategies

  2. Description of diagnostic activities

    Time frame: Every year up to 5 years

    Evaluation of diagnostic activities

  3. Description of surgical strategies

    Time frame: Every year up to 5 years

    Evaluation of surgical strategies

  4. 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)

  5. Description of each surgical approach

    Time frame: Every year up to 5 years

    Description of each surgical approach

  6. 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

  7. Patients' quality of life

    Time frame: Every year up to 5 years

    Patients' quality of life using questionnaires

  8. Patients' reported outcome

    Time frame: Every year up to 5 years

    Patients' reported outcome using questionnaires

  9. 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

  10. 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

  11. 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

  12. 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

  13. Survival analysis for each tumor

    Time frame: Every 2 years up to 6 years

    Survival analysis for each tumor

  14. Life status assessment for each patient

    Time frame: Every year up to 5 years

    Life status assessment for each patient

Study contacts

Contact information is provided by the study sponsor or research team.

Sandro Pignata, M.D.

CONTACT

[email protected]

08117770755

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2024
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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